Details for New Drug Application (NDA): 209861
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The generic ingredient in BEXAROTENE is bexarotene. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bexarotene profile page.
Summary for 209861
Tradename: | BEXAROTENE |
Applicant: | Ani Pharms |
Ingredient: | bexarotene |
Patents: | 0 |
Suppliers and Packaging for NDA: 209861
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BEXAROTENE | bexarotene | CAPSULE;ORAL | 209861 | ANDA | ANI Pharmaceuticals, Inc. | 43975-315 | 43975-315-10 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
Approval Date: | May 8, 2018 | TE: | AB | RLD: | No |
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