| 70771-1558-8 |
70771-1558 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Lifesciences Limited |
ISOTRETINOIN |
20 mg/1 |
3 BLISTER PACK in 1 CARTON (70771-1558-8) / 10 CAPSULE in 1 BLISTER PACK |
| 70771-1559-8 |
70771-1559 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Lifesciences Limited |
ISOTRETINOIN |
30 mg/1 |
3 BLISTER PACK in 1 CARTON (70771-1559-8) / 10 CAPSULE in 1 BLISTER PACK |
| 70771-1560-4 |
70771-1560 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Lifesciences Limited |
ISOTRETINOIN |
40 mg/1 |
10 BLISTER PACK in 1 CARTON (70771-1560-4) / 10 CAPSULE in 1 BLISTER PACK |
| 70771-1560-8 |
70771-1560 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Lifesciences Limited |
ISOTRETINOIN |
40 mg/1 |
3 BLISTER PACK in 1 CARTON (70771-1560-8) / 10 CAPSULE in 1 BLISTER PACK |
| 70771-1558-4 |
70771-1558 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Lifesciences Limited |
ISOTRETINOIN |
20 mg/1 |
10 BLISTER PACK in 1 CARTON (70771-1558-4) / 10 CAPSULE in 1 BLISTER PACK |
| 70771-1557-8 |
70771-1557 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Lifesciences Limited |
ISOTRETINOIN |
10 mg/1 |
3 BLISTER PACK in 1 CARTON (70771-1557-8) / 10 CAPSULE in 1 BLISTER PACK |
| 70771-1557-4 |
70771-1557 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Lifesciences Limited |
ISOTRETINOIN |
10 mg/1 |
10 BLISTER PACK in 1 CARTON (70771-1557-4) / 10 CAPSULE in 1 BLISTER PACK |
| 70710-1022-4 |
70710-1022 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Pharmaceuticals USA Inc. |
ISOTRETINOIN |
10 mg/1 |
10 BLISTER PACK in 1 CARTON (70710-1022-4) / 10 CAPSULE in 1 BLISTER PACK |
| 70710-1024-8 |
70710-1024 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Pharmaceuticals USA Inc. |
ISOTRETINOIN |
30 mg/1 |
3 BLISTER PACK in 1 CARTON (70710-1024-8) / 10 CAPSULE in 1 BLISTER PACK |
| 70710-1025-4 |
70710-1025 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Pharmaceuticals USA Inc. |
ISOTRETINOIN |
40 mg/1 |
10 BLISTER PACK in 1 CARTON (70710-1025-4) / 10 CAPSULE in 1 BLISTER PACK |
| 70710-1025-8 |
70710-1025 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Pharmaceuticals USA Inc. |
ISOTRETINOIN |
40 mg/1 |
3 BLISTER PACK in 1 CARTON (70710-1025-8) / 10 CAPSULE in 1 BLISTER PACK |
| 70710-1022-8 |
70710-1022 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Pharmaceuticals USA Inc. |
ISOTRETINOIN |
10 mg/1 |
3 BLISTER PACK in 1 CARTON (70710-1022-8) / 10 CAPSULE in 1 BLISTER PACK |
| 70710-1023-4 |
70710-1023 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Pharmaceuticals USA Inc. |
ISOTRETINOIN |
20 mg/1 |
10 BLISTER PACK in 1 CARTON (70710-1023-4) / 10 CAPSULE in 1 BLISTER PACK |
| 70710-1023-8 |
70710-1023 |
HUMAN PRESCRIPTION DRUG |
Isotretinoin |
Isotretinoin |
CAPSULE |
ORAL |
20230912 |
N/A |
ANDA |
ANDA211568 |
Zydus Pharmaceuticals USA Inc. |
ISOTRETINOIN |
20 mg/1 |
3 BLISTER PACK in 1 CARTON (70710-1023-8) / 10 CAPSULE in 1 BLISTER PACK |