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FDA first-time generics approvals--2012.

FDA First-Time Generics Approvals--2012

GENERIC DRUG NAME                MANUFACTURER        BRAND NAME

JANUARY

Polyethylene Glycol 3350,        Novel               Moviprep for
Sodium Sulfate, Sodium           Laboratories        Oral Solution
Chloride, Potassium Chloride,
Sodium Ascorbate and Ascorbic
Acid for Oral Solution

FEBRUARY

Cisatracurium Besylate           Sandoz              Nimbex Injection
Injection, 2 mg (base)/ml;
packaged in 20 mg (base)/(10
ml multiple-dose vials

Cisatracurium Besylate           Sandoz              Nimbex Injection
Injection, (preservative free)
10 mg (base)/ml packaged in
200 mg (base)/20 ml and 2 mg
(baseyml packaged in 100 mg
(base)/5 ml single-dose vials

Tizanidine Hydrochloride         Apotex              Zanaflex
Capsules, 2 mg (base), 4 mg                          Capsules
(base) and 6 mg (base)

Doxycycline Hyclate Delayed-     Mylan               Doryx Delayed
Release Tablets USP, 150 mg                          ReleaseTablets
(base)

Progesterone Capsules, 100 mg    Teva                Prometrium
and 200 mg                                           Capsules

MARCH

Fenofibrate Capsules, 43 mg      Dr. Reddy's         Antara Capsules
and 130 mg

Ziprasidone Hydrochloride        Lupin               Geodon
Capsules, 20 mg (base), 40 mg                        Capsules
(base), 60 mg (base) and 80 mg
(base)

Ziprasidone Hydrochloride        Apotex              Geodon
Capsules, 20 mg (base), 40 mg                        Capsules
(base), 60 mg (base) and 80 mg
(base)

Ziprasidone Hydrochloride        Dr. Reddy's         Geodon
Capsules, 20 mg (Base), 40 mg                        Capsules
(base), 60 mg (base) and 80 mg
(base)

Glycopyrrolate Tablets USP,      Nexgen              Robinul Forte
1.5 mg                                               Tablets

Escitalopram Oxalate Oral        Amneal              Lexapro Oral
Solution, 5 mg (base)/5 ml                           Solution

Escitalopram Tablets USP, 5      Ivax                Lexapro Tablets
mg, 10 mg and 20 mg

Ibandronate Sodium Tablets,      Apotex              Boniva Tablets
150 mg (base), once monthly

Ibandronate Sodium Tablets,      Orchid              Boniva Tablets
150 mg (base) (once-monthly)     Healthcare

Ibandronate Sodium Tablets,      Mylan               Boniva Tablets
150 mg (base), once monthly

Quetiapine Fumarate Tablets,     Accord              Seroquel Tablets
25 mg (base), 50 mg (base),      Healthcare
100 mg (base), 200 mg (base),
300 mg (base) and 400 mg
(base)

Quetiapine Fumarate Tablets,     Sun Pharma          Seroquel Tablets
25 mg (base), 50 mg (base),      Global
100 mg (base), 200 mg (base),
300 mg (base) and 400 mg
(base)

Quetiapine Fumarate Tablets,     Dr. Reddy's         Seroquel Tablets
25 mg (base), 50 mg (base),
100 mg (base), 150 mg (base),
200 mg (base), 300 mg (base)
and 400 mg (base)

Quetiapine Fumarate Tablets,     Aurobindo           Seroquel Tablets
25 mg (base), 50 mg (base),
100 mg (base) 150 mg (base),
200 mg (base), 300 mg (base)
and 400 mg (base)

Quetiapine Fumarate Tablets,     Apotex              Seroquel Tablets
25 mg (base), 50 mg (base),
100 mg (base), 200 mg (base),
300 mg (base) and 400 mg
(base)

Quetiapine Fumarate Tablets,     Teva                Seroquel Tablets
25 mg (base), 50 mg (base),
100 mg (base), 150 mg (base),
200 mg (base), 300 mg (base)
and 400 mg (base)

Quetiapine Fumarate Tablets,     Roxane              Seroquel Tablets
25 mg (base)

Quetiapine Fumarate Tablets,     Roxane              Seroquel Tablets
50 mg (base), 100 mg (base),
200 mg (base), 300 mg (base)
and 400 mg (base)

Quetiapine Fumarate Tablets,     Torrent             Seroquel Tablets
25 mg (base), 50 mg (base),      Pharmaceuticals
100 mg (base), 200 mg (base),
300 mg (base) and 400 mg
(base)

Quetiapine Fumarate Tablets,     Lupin               Seroquel Tablets
25 mg (base), 50 mg (base),
100 mg (base), 200 mg (base),
300 mg (base) and 400 mg
(base)

Quetiapine Fumarate Tablets,     Mylan               Seroquel Tablets
25 mg (base)

Irbesartan and                   Teva                Avalide Tablets
Hydrochlorothiazide Tablets
USP, 150 mg/12.5 mg, 300
mg/12.5 mg and 300 mg/25 mg

Irbesartan Tablets USP, 75 mg,   Teva                Avapro Tablets
150 mg and 300 mg

APRIL

Vancomycin Hydrochloride         Strides Arcolab     Vancocin
Capsules USP,125 mg (base) and                       Hydrochloride
250 mg (base)                                        Capsules

Vancomycin Hydrochloride         Watson              Vancocin
Capsules USP, 125 mg (base)                          Hydrochloride
and 250 mg (base)                                    Capsules

Vancomycin Hydrochloride         Akorn               Vancocin
Capsules USP, 125 mg (base)                          Hydrochloride
and 250 mg (base)                                    Capsules

Fluvastatin Capsules USP, 20     Mylan               Lescol Capsules
mg and 40 mg

Amino Acids Injection, 15%       B. Braun            Novamine
                                 Medical             Injection 15%

Tinidazole Tablets, 250 mg and   Novel               Tindamax
500 mg                           Laboratories        Tablets

Tinidazole Tablets, 250 mg and   Roxane              Tindamax
500 mg                                               Tablets

MAY

Vardenafil Hydrochloride         Teva                Levitra Tablets
Tablets, 2.5 mg, 5 mg, 10 mg
and 20 mg

Carbidopa, Levodopa and Enta-    Sun Pharma          Stalevo Tablets
capone Tablets, 25 mg/100        Global
mg/200 mg and 37.5 mg/150
mg/200 mg

Clopidogrel Tablets USP, 75 mg   Aurobindo           Plavix Tablets
                                                     75 mg

Clopidogrel Tablets USP, 300     Teva                Plavix Tablets
mg

Clopidogrel Tablets USP, 75 mg   Sun Pharma          Plavix Tablets
                                 Global

Clopidogrel Tablets USP, 75      Torrent             Plavix Tablets
mg                               Pharmaceuticals

Clopidogrel Tablets USP, 75 mg   Mylan               Plavix Tablets
and 300 mg

Clopidogrel Tablets USP, 75 mg   Teva                Plavix Tablets
                                                     75 mg

Clopidogrel Tablets USP, 300     Gate                Plavix Tablets
mg                               Pharmaceuticals     300 mg

Clopidogrel Tablets USP, 75 mg   Roxane              Plavix Tablets
                                                     75 mg

Clopidogrel Tablets USP, 300     Dr. Reddy's         Plavix Tablets
mg                                                   300 mg

Ropinirole Hydrochloride         Actavis South       Requip XL
Extended-Release Tablets, 4 mg   Atlantic            Tablets
(base), 6 mg (base), 8 mg
(base) and 12 mg (base)

Clopidogrel Tablets USP, 75 mg   Apotex              Plavix Tablets
                                                     75 mg

Butoconazole Nitrate Vaginal     Perrigo Israel      Gynazole-1
Cream USP, 2%                    Pharmaceuticals     Vaginal Cream

Lansoprazole Delayed-Release     Perrigo R&D         Prevacid 24 Hour
Capsules USP (OTC), 15 mg                            Delayed-Release
                                                     Capsules

Lansoprazole Delayed-Release     Dr. Reddy's         Prevacid 24 Hour
Capsules USP (OTC), 15 mg                            Delayed-Release
                                                     Capsules

Lansoprazole Delayed-Release     Wockhardt           Prevacid 24 Hour
Capsules USP (OTC), 15 mg

Minocycline Hydrochloride        Barr Laboratories   Solodyn
Extended-Release Tablets 65 mg                       Extended
(base), 115 mg (base)                                Release Tablets

Nevirapine Tablets USP, 200 mg   Micro Labs          Viramune
                                                     Tablets

Nevirapine Tablets USP, 200 mg   Cipla               Viramune
                                                     Tablets

Nevirapine Tablets USP, 200 mg   Aurobindo           Viramune
                                                     Tablets

Nevirapine Oral Suspension       Aurobindo           Viramune Oral
USP, 50 mg/5 ml                                      Suspension

Nevirapine Tablets USP, 200 mg   Hetero Labs         Viramune
                                                     Tablets

Nevirapine Tablets USP, 200 mg   Prinston            Viramune
                                 Pharmaceutical,     Tablets

Nevirapine Tablets USP, 200 mg   Mylan               Viramune
                                                     Tablets

Nevirapine Tablets USP, 200 mg   Sciegen             Viramune
                                 Pharmaceuticals,    Tablets

Nevirapine Tablets USP, 200 mg   Mylan               Viramune
                                                     Tablets

Nevirapine Tablets USP, 200 mg   Apotex              Viramune
                                                     Tablets

Nevirapine Tablets USP, 200 mg   Strides Arcolab     Viramune
                                                     Tablets

Dextromethorphan Polistirex      Tris Pharma         Delsym
Extended-Release Suspension,                         Extended
30 mg/5 ml                                           Release Cough
                                                     Suppressant

Calcipotriene Cream, 0.005%      Tolmar              Dovonex Cream

Voriconazole for Injection,      Sandoz              Vfend I.V. for
200 mg single-dose vials                             Injection

JUNE

Armodafinil Tablets 50 mg, 150   Mylan               NuvigilTablets
mg, 250 mg

Adapalene Gel, 0.3%              Tolmar              Differin Gel, 0.3%

Abacavir Tablets USP, 300 mg     Mylan               Ziagen Tablets

Olanzapine and Fluoxetine        Teva                Symbyax
Capsules USP, 6 mg/25 mg                             Capsules
(base), 12 mg/25 mg (base), 6
mg/50 mg (base) and 12 mg/50
mg (base)

Dextroamphetamine Saccharate,    Actavis             Adderall XR
Amphetamine Asparate Monohy-     Elizabeth           Capsules
drate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Extended- Release
Capsules, 5 mg, 10 mg, 15 mg,
20 mg, 25 mg and 30 mg

Clindamycin Phosphate And        Perrigo Israel      Duac Topical Gel
Benzoyl Peroxide Gel, 1.2%/5%    Pharmaceuticals

Linezolid Injection, 2 mg/ml,    Teva                Zyvox Injection
packaged in 600 mg/300 ml                            600 mg/300 ml
single-use flexible plastic
containers

Cidofovir Injection, 75 mg/ml,   Mylan               Vistide Injection
pack- aged in 375 mg/5 ml        Institutional
single-use vials

JULY

Pregabalin Capsules, 75 mg,      Teva                Lyrica Capsules
100 mg, 150 mg, 200 mg, 225 mg
and 300 mg

Pregabalin Capsules, 25 mg and   Teva                Lyrica Capsules
50 mg

Pregabalin Capsules, 25 mg, 50   Watson              Lyrica Capsules
mg, 75 mg, 100 mg, 150 mg, 200
mg, 225 mg and 300 mg

Pregabalin Capsules, 25 mg, 50   Lupin               Lyrica Capsules
mg, 75 mg, 100 mg, 150 mg, 200
mg, 225 mg and 300 mg

Diclofenac Sodium and            Watson--Florida     Arthrotec Tablets
Misoprostol Delayed-Release
Tablets, 50 mg/0.2 mg and 75
mg/0.2 mg

Levonorgestrel Tablets (Rx &     Watson              Plan B One Step
OTC), 1.5 Mg

Phenoxybenzamine Hydrochloride   Roxane              Dibenzyline
Capsules USP, 10 mg                                  Capsules

Modafanil Tablets USP, 100 mg    Mylan               Provigil Tablets
and 200 mg

Entacapone Tablets USP, 200 mg   Sun Pharma Global   Comtan Tablets

Methylphenidate Hydrochloride    Teva                Metadate CD
Extended-Release Capsules                            Extended-Release
(CD), 10 mg, 20 mg and 30 mg                         Capsules
(once daily)

Methylphenidate Hydrochloride    Teva                Metadate CD
Extended-Release Capsules                            Extended-Release
(CD), 40 mg, 50 mg and 60 mg                         Capsules
(once daily)

Fexofenadine Hydrochloride       Actavis Mid-        Allegra Oral
Oral Suspension, 30 mg/5 ml      Atlantic            Suspension

Oxycodone Hydrochloride Oral     Vistapharm          Oxycodone
Solution USP, 100 mg/5 ml                            Hydrochloride
                                                     Oral Solution

AUGUST

Montelukast Sodium Tablets,      Roxane              Singulair Tablets
10 mg (base)

Montelukast Sodium Chewable      Mylan               Singulair Chewable
Tablets, 4 mg (base) and 5 mg                        Tablets
(base)

Montelukast Sodium Tablets,      Glenmark Generics   Singulair Tablets
10 mg (base)

Montelukast Sodium Tablets,      Kudco Ireland       Singulair Tablets
10 mg (base)

Montelukast Sodium Chewable      Kudco Ireland       Singulair Chewable
Tablets, 4 mg (base) and 5 mg                        Tablets
(base)

MontelukastSodium Tablets,       Endo                Singulair Tablets
10 mg (base)

Montelukast Sodium Chewable      Endo                Singulair Chewable
Tablets, 4 mg (base) and 5 mg                        Tablets
(base)

MontelukastSodium Tablets,       Aurobindo           Singulair Tablets
10 mg (base)

Montelukast Sodium Chewable      Aurobindo           Singulair Chewable
Tablets, 4 mg (base) and 5 mg                        Tablets
(base)

Montelukast Sodium Chewable      Apotex              Singulair Chewable
Tablets, 4 mg (base) and 5 mg                        Tablets
(base)

Montelukast Sodium Oral          Teva                Singulair Oral
Granules, 4 mg (base),                               Granules
single-dose packet

Montelukast Sodium Chewable      Teva                Singulair Chewable
Tablets, 4 mg (base) and 5 mg                        Tablets
(base)

MontelukastSodium Tablets,       Mylan               Singulair Tablets
10 mg (base)

Montelukast Sodium Tablets,      Teva                Singulair Tablets
10 mg (base)

Montelukast Sodium Chewable      Roxane              Singulair Chewable
Tablets, 4 mg (base) and 5 mg                        Tablets
(base)

MontelukastSodium Tablets,       Sandoz              Singulair Tablets
10 mg (base)

Montelukast Sodium Chewable      Torrent             Singulair Chewable
Tablets, 4 mg (base) and 5 mg    Pharmaceuticals     Tablets
(base)

Montelukast Sodium Tablets,      Torrent             Singulair Tablets
10 mg (base)                     Pharmaceuticals

MontelukastSodium Tablets,       Apotex              Singulair Tablets
10 mg (base)

Didanosine Tablets For Oral      Aurobindo           Videx Tablets
Suspension USP, 100 mg, 150 mg
and 200 mg (chewable,
dispersible, buffered)

Clobetasol Propionate Foam       Perrigo Israel      Olux E Foam
(emollient formulation), 0.05%   Pharmaceuticals

Pioglitazone Tablets USP,        Mylan               Actos Tablets
15 mg, 30 mg and 45 mg

Mycophenolic Acid Delayed-       Apotex.             Myfortic
Release Tablets, 180 mg                              Delayed-Release
                                                     Tablets

Nedocromil Sodium Ophthalmic     Akorn               Alocril Ophthalmic
Solution, 2%                                         Solution

Lidocaine Patch, 5%              Watson              Lidoderm Patch
Armodafinil Tablets, 100 mg      Watson              NuvigilTablets
and 200 mg

Azelastine Hydrochloride Nasal   Apotex              Astepro Nasal
Solution, (nasal spray), 0.15%                       Spray
[0.187 mg (baseyspray]

SEPTEMBER

Valsartan and                    Mylan               Diovan HCT
Hydrochlorothiazide Tablets,                         Tablets
80 mg/12.5 mg, 160 mg/12.5 mg,
160 mg/25 mg, 320 mg/12.5 mg
and 320 mg/25 mg

Aprepitant Capsules, 40 mg, 80   Sandoz              Emend
mg and 125 mg                                        Capsules

Amlodipine, Valsartan and        Teva                Exforge HCT
Hydro/chlorothiazide Tablets,                        Tablets
5 mg/160 mg/12.5 mg, 10 mg/
160 mg/12.5 mg, 5 mg/160 mg/
25 mg, 10 mg/160 mg/25 mg and
10 mg/320 mg/25 mg

Quinine Sulfate Capsules USP,    Teva                Qualaquin
324 mg                                               Capsules

Progesterone Capsules, 100 mg    Sofgen              Prometrium
and 200 mg                       Pharmaceuticals     Capsules

OCTOBER

Guanfacine Extended-Release      Actavis Elizabeth   Intuniv Extended
Tablets, 1 mg, 2 mg, 3 mg and                        Release Tablets
4 mg

Nicotine Polacrilex Lozenges     Perrigo R&D         Nicorette Mini
(mini lozenges, OTC), 2 mg and                       Lozenges
4 mg (mint-flavored)

Tretinoin Cream USP, 0.075%      Precision           Retin-A Cream
                                 Dermatology

Trospium Chloride Extended-      Watson--Florida     Sanctura XR
Release Capsules, 60 mg                              Capsules

Ultramicrosize Griseofulvin      Sigmapharm          Gris-PegTablets
Tablets USP, 125 mg and 250 mg   Laboratories

Tretinoin Capsules, 10 mg        Anchen              Vesanoid
                                 Pharmaceuticals     Capsules

NOVEMBER

Sildenafil Tablets, 20 mg        Torrent             Revatio Tablets
                                 Pharmaceuticals

Sildenafil Tablets, 20 mg        Apotex              Revatio Tablets

Sildenafil Tablets, 20 mg        Watson              Revatio Tablets

Sildenafil Tablets, 20 mg        Dr. Reddy's         Revatio Tablets

Acetylcysteine Injection, 200    Innopharma          Acetadote
mg-ml, packaged in 6 g-30 ml                         Injection
single-use vials

Pantoprazole Sodium for          Akorn               Protonix I.V. for
Injection, 40 mg (baseysingle-                       Injection
dose vial

Carbidopa, Levodopa and          Wockhardt           Stalevo
Entacapone Tablets, 18.75 mg/
75 mg/200 mg, 25 mg/100 mg/
200 mg, 31.25 mg/125 mg/200
mg, 37.5 mg/150 mg/200 mg, and
50 mg/200 mg/200 mg

Carbidopa, Levodopa and          Wockhardt           Stalevo-50
Entacapone Tablets, 12.5 mg/50                       Tablets
mg/200 mg

BetamethasoneValerate Foam,      Cobrek              Luxiq Foam
0.12%                            Pharmaceuticals

DECEMBER

Candesartan Cilexetil and        Mylan               Atacand-HCT
Hydrochlorothiazide Tablets,                         Tablets
16 mg/12.5 mg, 32 mg/12.5 mg
and 32 mg/25 mg

Ammonia N 13 Injection USP,      Houston Cyclotron   Ammonia N 13
3.75-260 mCi/ml at EOS           Partners            Injection USP

Sodium Fluoride F-18 Injection   Houston Cyclotron   Sodium Fluoride
USP,10-200 mCi/ml at EOS         Partners            F-18 Injection USP

Phenytoin Chewable Tablets       Mylan               Dilantin Chewable
USP, 50 mg                                           Tablets

Lamotrigine Extended-Release     Anchen              Lamictal XR
Tablets (once a day), 25 mg,     Pharmaceuticals     Extended-Release
50 mg, 100 mg, 200 mg, 250 mg                        Tablets
and 300 mg

Tranexamic Acid Tablets, 650     Watson--Florida     Lysteda
mg                                                   Tablets
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Title Annotation:RX: RETAIL PHARMACY: Generic Drug Report
Publication:Chain Drug Review
Date:Feb 18, 2013
Words:2086
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