Details for New Drug Application (NDA): 215402
✉ Email this page to a colleague
NDA 215402 describes ETRAVIRINE, which is a drug marketed by Amneal and Carnegie and is included in two 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the etravirine profile page.
Summary for 215402
| Tradename: | ETRAVIRINE |
| Applicant: | Carnegie |
| Ingredient: | etravirine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215402
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETRAVIRINE | etravirine | TABLET;ORAL | 215402 | ANDA | Leading Pharma, LLC | 69315-285 | 69315-285-20 | 120 TABLET in 1 BOTTLE (69315-285-20) |
| ETRAVIRINE | etravirine | TABLET;ORAL | 215402 | ANDA | Leading Pharma, LLC | 69315-286 | 69315-286-06 | 60 TABLET in 1 BOTTLE (69315-286-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 13, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Apr 13, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
