Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214196
Company: AMNEAL

Products on ANDA 214196

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214196

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

Therapeutic Equivalents for ANDA 214196

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