Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078886
Company: HETERO LABS LTD III

Products on ANDA 078886

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EFAVIRENZ	EFAVIRENZ	600MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078886

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078886_TA_PEPFAR_LTR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2023	SUPPL-27	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078886

EFAVIRENZ

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFAVIRENZ	EFAVIRENZ	600MG	TABLET;ORAL	Prescription	No	AB	077673	AUROBINDO PHARMA LTD
EFAVIRENZ	EFAVIRENZ	600MG	TABLET;ORAL	Prescription	No	AB	204766	CIPLA
EFAVIRENZ	EFAVIRENZ	600MG	TABLET;ORAL	Prescription	No	AB	078886	HETERO LABS LTD III
EFAVIRENZ	EFAVIRENZ	600MG	TABLET;ORAL	Prescription	No	AB	204869	STRIDES PHARMA