Details for New Drug Application (NDA): 202148
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NDA 202148 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.
Suppliers and Packaging for NDA: 202148
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACITRETIN | acitretin | CAPSULE;ORAL | 202148 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7020 | 0378-7020-93 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7020-93) |
| ACITRETIN | acitretin | CAPSULE;ORAL | 202148 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7023 | 0378-7023-93 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 10, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 10, 2015 | TE: | AB | RLD: | No | ||||
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