Details for New Drug Application (NDA): 091455
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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.
Summary for 091455
Tradename: | ACITRETIN |
Applicant: | Barr Labs Inc |
Ingredient: | acitretin |
Patents: | 0 |
Suppliers and Packaging for NDA: 091455
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACITRETIN | acitretin | CAPSULE;ORAL | 091455 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1135 | 0093-1135-56 | 30 CAPSULE in 1 BOTTLE (0093-1135-56) |
ACITRETIN | acitretin | CAPSULE;ORAL | 091455 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1136 | 0093-1136-56 | 30 CAPSULE in 1 BOTTLE (0093-1136-56) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 4, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Apr 4, 2013 | TE: | AB | RLD: | No |
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