Details for New Drug Application (NDA): 209931
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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 209931
Tradename: | BEXAROTENE |
Applicant: | Teva Pharms Usa |
Ingredient: | bexarotene |
Patents: | 0 |
Suppliers and Packaging for NDA: 209931
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BEXAROTENE | bexarotene | CAPSULE;ORAL | 209931 | ANDA | Actavis Pharma, Inc. | 0591-2832 | 0591-2832-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0591-2832-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
Approval Date: | Jan 14, 2021 | TE: | AB | RLD: | No |
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