Details for New Drug Application (NDA): 213571
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NDA 213571 describes ISOTRETINOIN, which is a drug marketed by Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Upsher Smith Labs, and Zydus Pharms, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the ISOTRETINOIN profile page.
The generic ingredient in ISOTRETINOIN is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
The generic ingredient in ISOTRETINOIN is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 213571
| Tradename: | ISOTRETINOIN |
| Applicant: | Upsher Smith Labs |
| Ingredient: | isotretinoin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213571
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 213571 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0575 | 0245-0575-01 | 3 BLISTER PACK in 1 BOX (0245-0575-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0575-89) |
| ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 213571 | ANDA | Mayne Pharma | 68308-575 | 68308-575-30 | 3 BLISTER PACK in 1 BOX (68308-575-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 12, 2021 | TE: | AB2 | RLD: | No | ||||
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