Details for New Drug Application (NDA): 210105
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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 210105
Tradename: | BEXAROTENE |
Applicant: | Amneal Pharms Ny |
Ingredient: | bexarotene |
Patents: | 0 |
Suppliers and Packaging for NDA: 210105
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BEXAROTENE | bexarotene | CAPSULE;ORAL | 210105 | ANDA | AvKARE | 42291-072 | 42291-072-01 | 100 CAPSULE in 1 BOTTLE (42291-072-01) |
BEXAROTENE | bexarotene | CAPSULE;ORAL | 210105 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1250 | 69238-1250-1 | 1 BOTTLE in 1 CARTON (69238-1250-1) / 100 CAPSULE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
Approval Date: | Sep 4, 2018 | TE: | AB | RLD: | No |
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