| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Roxane |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg, 12.5 mg/100 mg and 25 mg/100 mg tabs. |
77-732 |
10/6/2010 |
| Lupin |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
78-232 |
10/6/2010 |
| Zydus |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
78-243 |
10/6/2010 |
| Lupin |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg, 12.5 mg/100 mg and 25 mg/100 mg tabs. |
78-245 |
10/6/2010 |
| Zydus |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg and 12.5 mg/100 mg tabs. |
78-385 |
10/6/2010 |
| Apotex |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg, 12.5 mg/100 mg and 25 mg/100 mg tabs. |
90-150 |
10/6/2010 |
| Actavis |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-382 |
10/6/2010 |
| Alembic |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-428 |
10/6/2010 |
| Torrent |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-467 |
10/6/2010 |
| Torrent |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg, 12.5 mg/100 mg and 25 mg/100 mg tabs. |
90-528 |
10/6/2010 |
| Upsher |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-544 |
10/6/2010 |
| Aurobindo |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg, 12.5 mg/100 mg and 25 mg/100 mg tabs. |
91-629 |
10/6/2010 |
| Mylan |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg, 12.5 mg/100 mg and 25 mg/100 mg tabs. |
91-652 |
10/6/2010 |
| Vintage |
Griseofulvin, 125 mg/5 mL oral suspension |
65-438 |
10/8/2010 |
| Mylan |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
77-854 |
10/8/2010 |
| Watson |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
78-551 |
10/8/2010 |
| Alembic |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
78-894 |
10/8/2010 |
| Sandoz |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg and 1.5 mg tabs. |
90-190 |
10/8/2010 |
| Teva |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg and 1.5 mg tabs. |
90-241 |
10/8/2010 |
| Hetero |
Levetiracetam, 250 mg, 500 mg, 750 mg and 1 gm tabs. |
90-515 |
10/8/2010 |
| Glenmark |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
90-781 |
10/8/2010 |
| Torrent |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg and 1.5 mg tabs. |
90-865 |
10/8/2010 |
| Breckenridge |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
91-450 |
10/8/2010 |
| Actavis |
Zolpidem tartrate, 6.25 mg extended-release tabs. |
78-179 |
10/13/2010 |
| Tentative Approvals |
| Mylan |
Clopidogrel bisulfate, 75 mg tabs. |
77-665 |
10/4/2010 |
| Synthon |
Zolpidem tartrate, 6.25 mg and 12.5 mg extended-release tabs. |
78-783 |
10/13/2010 |
| Actavis |
Zolpidem tartrate, 12.5 mg extended-release tabs. |
78-179 |
10/13/2010 |
| Sandoz |
Donepezil HCl, 5 mg and 10 mg tabs. |
90-290 |
10/13/2010 |