Details for New Drug Application (NDA): 205063
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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 |
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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