Details for New Drug Application (NDA): 208628
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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 208628
Tradename: | BEXAROTENE |
Applicant: | Ascent Pharms Inc |
Ingredient: | bexarotene |
Patents: | 0 |
Suppliers and Packaging for NDA: 208628
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BEXAROTENE | bexarotene | CAPSULE;ORAL | 208628 | ANDA | Ascent pharmaceutical Inc | 43602-176 | 43602-176-01 | 1 BOTTLE in 1 CARTON (43602-176-01) / 100 CAPSULE in 1 BOTTLE |
BEXAROTENE | bexarotene | CAPSULE;ORAL | 208628 | ANDA | Ascent pharmaceutical Inc | 43602-176 | 43602-176-05 | 1 BOTTLE in 1 CARTON (43602-176-05) / 500 CAPSULE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
Approval Date: | Sep 6, 2024 | TE: | AB | RLD: | No |
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