Details for New Drug Application (NDA): 217774
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The generic ingredient in ACITRETIN is acitretin. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acitretin profile page.
Suppliers and Packaging for NDA: 217774
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACITRETIN | acitretin | CAPSULE;ORAL | 217774 | ANDA | Alembic Pharmaceuticals Limited | 46708-741 | 46708-741-30 | 30 CAPSULE in 1 BOTTLE (46708-741-30) |
ACITRETIN | acitretin | CAPSULE;ORAL | 217774 | ANDA | Alembic Pharmaceuticals Limited | 46708-742 | 46708-742-30 | 30 CAPSULE in 1 BOTTLE (46708-742-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 5, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 17.5MG | ||||
Approval Date: | Aug 5, 2024 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Aug 5, 2024 | TE: | AB | RLD: | No |
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