Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078064
Company: AUROBINDO PHARMA

Products on ANDA 078064

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EFAVIRENZ	EFAVIRENZ	50MG	CAPSULE;ORAL	Prescription	AB	No	No
EFAVIRENZ	EFAVIRENZ	100MG	CAPSULE;ORAL	Prescription	None	No	No
EFAVIRENZ	EFAVIRENZ	200MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078064

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/078064Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/20/2024	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/04/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078064

EFAVIRENZ

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFAVIRENZ	EFAVIRENZ	50MG	CAPSULE;ORAL	Prescription	No	AB	078064	AUROBINDO PHARMA

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFAVIRENZ	EFAVIRENZ	200MG	CAPSULE;ORAL	Prescription	No	AB	078064	AUROBINDO PHARMA