An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 079188
Company: AUROBINDO PHARMA LTD

Products on ANDA 079188

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079188

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/2023	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079188s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/079188Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 079188

EMTRICITABINE

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	No	AB	079188	AUROBINDO PHARMA LTD
EMTRICITABINE	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	No	AB	091168	CIPLA
EMTRIVA	EMTRICITABINE	200MG	CAPSULE;ORAL	Prescription	Yes	AB	021500	GILEAD

Top