| 71335-2984-1 |
71335-2984 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20251030 |
N/A |
ANDA |
ANDA212708 |
Bryant Ranch Prepack |
PIRFENIDONE |
801 mg/1 |
90 TABLET, COATED in 1 BOTTLE (71335-2984-1) |
| 62332-480-71 |
62332-480 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20220610 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Inc. |
PIRFENIDONE |
801 mg/1 |
500 TABLET, COATED in 1 BOTTLE (62332-480-71) |
| 62332-480-90 |
62332-480 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20220610 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Inc. |
PIRFENIDONE |
801 mg/1 |
90 TABLET, COATED in 1 BOTTLE (62332-480-90) |
| 72162-2466-9 |
72162-2466 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20250306 |
N/A |
ANDA |
ANDA212708 |
Bryant Ranch Prepack |
PIRFENIDONE |
801 mg/1 |
90 TABLET, COATED in 1 BOTTLE (72162-2466-9) |
| 62332-479-27 |
62332-479 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20221122 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Inc. |
PIRFENIDONE |
267 mg/1 |
270 TABLET, COATED in 1 BOTTLE (62332-479-27) |
| 62332-479-64 |
62332-479 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20220610 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Inc. |
PIRFENIDONE |
267 mg/1 |
3 BOTTLE in 1 CARTON (62332-479-64) / 90 TABLET, COATED in 1 BOTTLE |
| 62332-479-71 |
62332-479 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20220610 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Inc. |
PIRFENIDONE |
267 mg/1 |
500 TABLET, COATED in 1 BOTTLE (62332-479-71) |
| 46708-480-71 |
46708-480 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20220610 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Limited |
PIRFENIDONE |
801 mg/1 |
500 TABLET, COATED in 1 BOTTLE (46708-480-71) |
| 46708-480-90 |
46708-480 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20220610 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Limited |
PIRFENIDONE |
801 mg/1 |
90 TABLET, COATED in 1 BOTTLE (46708-480-90) |
| 72162-2465-2 |
72162-2465 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20250306 |
N/A |
ANDA |
ANDA212708 |
Bryant Ranch Prepack |
PIRFENIDONE |
267 mg/1 |
3 BOTTLE in 1 CARTON (72162-2465-2) / 90 TABLET, COATED in 1 BOTTLE |
| 72162-2465-4 |
72162-2465 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20250514 |
N/A |
ANDA |
ANDA212708 |
Bryant Ranch Prepack |
PIRFENIDONE |
267 mg/1 |
270 TABLET, COATED in 1 BOTTLE (72162-2465-4) |
| 72162-2465-9 |
72162-2465 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20250514 |
N/A |
ANDA |
ANDA212708 |
Bryant Ranch Prepack |
PIRFENIDONE |
267 mg/1 |
90 TABLET, COATED in 1 BOTTLE (72162-2465-9) |
| 46708-479-27 |
46708-479 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20221122 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Limited |
PIRFENIDONE |
267 mg/1 |
270 TABLET, COATED in 1 BOTTLE (46708-479-27) |
| 46708-479-64 |
46708-479 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20220610 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Limited |
PIRFENIDONE |
267 mg/1 |
3 BOTTLE in 1 CARTON (46708-479-64) / 90 TABLET, COATED in 1 BOTTLE |
| 46708-479-71 |
46708-479 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20220610 |
N/A |
ANDA |
ANDA212708 |
Alembic Pharmaceuticals Limited |
PIRFENIDONE |
267 mg/1 |
500 TABLET, COATED in 1 BOTTLE (46708-479-71) |
| 71335-2944-1 |
71335-2944 |
HUMAN PRESCRIPTION DRUG |
Pirfenidone |
Pirfenidone |
TABLET, COATED |
ORAL |
20251030 |
N/A |
ANDA |
ANDA212708 |
Bryant Ranch Prepack |
PIRFENIDONE |
267 mg/1 |
3 BOTTLE in 1 CARTON (71335-2944-1) / 90 TABLET, COATED in 1 BOTTLE |