Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215402
Company: CARNEGIE
Company: CARNEGIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETRAVIRINE | ETRAVIRINE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
ETRAVIRINE | ETRAVIRINE | 200MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/13/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ETRAVIRINE
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ETRAVIRINE | ETRAVIRINE | 100MG | TABLET;ORAL | Prescription | No | AB | 214196 | AMNEAL |
ETRAVIRINE | ETRAVIRINE | 100MG | TABLET;ORAL | Prescription | No | AB | 215402 | CARNEGIE |
INTELENCE | ETRAVIRINE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 022187 | JANSSEN R AND D |
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ETRAVIRINE | ETRAVIRINE | 200MG | TABLET;ORAL | Prescription | No | AB | 214196 | AMNEAL |
ETRAVIRINE | ETRAVIRINE | 200MG | TABLET;ORAL | Prescription | No | AB | 215402 | CARNEGIE |
INTELENCE | ETRAVIRINE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 022187 | JANSSEN R AND D |