Details for New Drug Application (NDA): 202552
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NDA 202552 describes ACITRETIN, which is a drug marketed by Alembic, Barr Labs Inc, Impax Labs Inc, Mylan, Norvium Bioscience, Sigmapharm Labs Llc, and Teva Pharms Usa, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the ACITRETIN profile page.
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.
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.
Summary for 202552
| Tradename: | ACITRETIN |
| Applicant: | Impax Labs Inc |
| Ingredient: | acitretin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202552
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACITRETIN | acitretin | CAPSULE;ORAL | 202552 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1750 | 0115-1750-08 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1750-08) |
| ACITRETIN | acitretin | CAPSULE;ORAL | 202552 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1751 | 0115-1751-08 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1751-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 23, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 17.5MG | ||||
| Approval Date: | Dec 23, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 22.5MG | ||||
| Approval Date: | Dec 23, 2015 | TE: | AB | RLD: | No | ||||
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