Details for New Drug Application (NDA): 077684
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The generic ingredient in TRETINOIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 077684
Tradename: | TRETINOIN |
Applicant: | Barr Labs Inc |
Ingredient: | tretinoin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077684
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRETINOIN | tretinoin | CAPSULE;ORAL | 077684 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0808 | 0555-0808-02 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0555-0808-02) |
TRETINOIN | tretinoin | CAPSULE;ORAL | 077684 | ANDA | Bryant Ranch Prepack | 63629-8752 | 63629-8752-1 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8752-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 22, 2007 | TE: | AB | RLD: | No |
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