Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214196
Company: AMNEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETRAVIRINE ETRAVIRINE 25MG TABLET;ORAL Discontinued None No No
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
06/14/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214196Orig1s000ltr.pdf

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
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
INTELENCE ETRAVIRINE 200MG TABLET;ORAL Prescription Yes AB 022187 JANSSEN R AND D

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