Details for New Drug Application (NDA): 218561
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NDA 218561 describes TRETINOIN, which is a drug marketed by Barr Labs Inc, Endo Operations, Glenmark Pharms Ltd, Alembic, Allergan, Padagis Us, Taro, Zo Skin Health, Zydus Lifesciences, Mylan, Norvium Bioscience, Teva Pharms, Wockhardt, and Encube, and is included in twenty-two NDAs. It is available from eighteen suppliers. Additional details are available on the TRETINOIN profile page.
The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 218561
| Tradename: | TRETINOIN |
| Applicant: | Zydus Lifesciences |
| Ingredient: | tretinoin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218561
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRETINOIN | tretinoin | CREAM;TOPICAL | 218561 | ANDA | Zydus Lifesciences Limited | 70771-1873 | 70771-1873-2 | 1 TUBE in 1 CARTON (70771-1873-2) / 20 g in 1 TUBE |
| TRETINOIN | tretinoin | CREAM;TOPICAL | 218561 | ANDA | Zydus Lifesciences Limited | 70771-1873 | 70771-1873-4 | 1 TUBE in 1 CARTON (70771-1873-4) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Apr 25, 2024 | TE: | AB | RLD: | No | ||||
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