Details for New Drug Application (NDA): 215398
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The generic ingredient in BEXAROTENE is bexarotene. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bexarotene profile page.
Summary for 215398
Tradename: | BEXAROTENE |
Applicant: | Amneal |
Ingredient: | bexarotene |
Patents: | 0 |
Suppliers and Packaging for NDA: 215398
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BEXAROTENE | bexarotene | GEL;TOPICAL | 215398 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2088 | 69238-2088-6 | 1 TUBE in 1 CARTON (69238-2088-6) / 60 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 1% | ||||
Approval Date: | Apr 27, 2022 | TE: | AB | RLD: | No |
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