Details for New Drug Application (NDA): 214196
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NDA 214196 describes ETRAVIRINE, which is a drug marketed by Amneal, Bionpharma, and Carnegie, and is included in three NDAs. It is available from four 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the etravirine profile page.
Summary for 214196
| Tradename: | ETRAVIRINE |
| Applicant: | Amneal |
| Ingredient: | etravirine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214196
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETRAVIRINE | etravirine | TABLET;ORAL | 214196 | ANDA | AvKARE | 42291-473 | 42291-473-12 | 120 TABLET in 1 BOTTLE (42291-473-12) |
| ETRAVIRINE | etravirine | TABLET;ORAL | 214196 | ANDA | AvKARE | 42291-474 | 42291-474-60 | 60 TABLET in 1 BOTTLE (42291-474-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jun 14, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 14, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jun 14, 2021 | TE: | AB | RLD: | No | ||||
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