Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215402
Company: CARNEGIE

Products on ANDA 215402

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215402

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.

Therapeutic Equivalents for ANDA 215402

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