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): 077411
Company: CIPLA

Products on ANDA 077411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/07/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77411TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2019	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
11/09/2016	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
11/09/2016	SUPPL-26	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077411

LAMIVUDINE AND ZIDOVUDINE

TABLET;ORAL; 150MG;300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	No	AB	206375	ANDA REPOSITORY
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	No	AB	077558	AUROBINDO PHARMA
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	No	AB	077411	CIPLA
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	No	AB	079124	HETERO LABS LTD III
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	No	AB	203259	HETERO LABS LTD V
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	No	AB	090246	LUPIN LTD
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	No	AB	090679	MACLEODS PHARMS LTD
LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET;ORAL	Prescription	No	AB	079128	STRIDES PHARMA

Top