Details for New Drug Application (NDA): 207792
✉ Email this page to a colleague
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 207792
Tradename: | ISOTRETINOIN |
Applicant: | Amneal Pharms Ny |
Ingredient: | isotretinoin |
Patents: | 0 |
Suppliers and Packaging for NDA: 207792
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 207792 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1017 | 69238-1017-3 | 3 BLISTER PACK in 1 CARTON (69238-1017-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1017-1) |
ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 207792 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1174 | 69238-1174-3 | 3 BLISTER PACK in 1 CARTON (69238-1174-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1174-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 29, 2017 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Sep 29, 2017 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
Approval Date: | Sep 29, 2017 | TE: | AB1 | RLD: | No |
Complete Access Available with Subscription