Details for New Drug Application (NDA): 219152
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NDA 219152 describes ETRAVIRINE, which is a drug marketed by Amneal, Bionpharma, and Carnegie, and is included in three NDAs. It is available from five suppliers. Additional details are available on the ETRAVIRINE profile page.
The generic ingredient in ETRAVIRINE is etravirine. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the etravirine profile page.
The generic ingredient in ETRAVIRINE is etravirine. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the etravirine profile page.
Summary for 219152
| Tradename: | ETRAVIRINE |
| Applicant: | Bionpharma |
| Ingredient: | etravirine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219152
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETRAVIRINE | etravirine | TABLET;ORAL | 219152 | ANDA | Bionpharma Inc. | 69452-254 | 69452-254-22 | 120 TABLET in 1 BOTTLE, PLASTIC (69452-254-22) |
| ETRAVIRINE | etravirine | TABLET;ORAL | 219152 | ANDA | Bionpharma Inc. | 69452-255 | 69452-255-17 | 60 TABLET in 1 BOTTLE, PLASTIC (69452-255-17) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 2, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Oct 2, 2025 | TE: | AB | RLD: | No | ||||
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