Details for New Drug Application (NDA): 208628
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NDA 208628 describes BEXAROTENE, which is a drug marketed by Amneal Pharms Ny, Ani Pharms, Ascent Pharms Inc, Bionpharma, Hikma, Teva Pharms Usa, Upsher Smith Labs, and Amneal, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the BEXAROTENE profile page.
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.
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 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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