Amnesteem
- Product NDC
- 0378-6613
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isotretinoin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA075945
- Marketing category
- ANDA
- Substance
- ISOTRETINOIN
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 0378-6613-93 | 3 BLISTER PACK in 1 CARTON (0378-6613-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6613-85) | 2025-04-10 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| Amnesteem - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2024-06-23 | HUMAN PRESCRIPTION DRUG LABEL | 23 |