Details for New Drug Application (NDA): 205063
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NDA 205063 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 205063
| Tradename: | ISOTRETINOIN |
| Applicant: | Actavis Labs Fl |
| Ingredient: | isotretinoin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205063
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 205063 | ANDA | Actavis Pharma, Inc. | 0591-2433 | 0591-2433-15 | 3 BLISTER PACK in 1 CARTON (0591-2433-15) / 10 CAPSULE in 1 BLISTER PACK (0591-2433-45) |
| ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 205063 | ANDA | Actavis Pharma, Inc. | 0591-2434 | 0591-2434-15 | 3 BLISTER PACK in 1 CARTON (0591-2434-15) / 10 CAPSULE in 1 BLISTER PACK (0591-2434-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 31, 2021 | TE: | AB2 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Mar 31, 2021 | TE: | AB2 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 31, 2021 | TE: | AB2 | RLD: | No | ||||
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