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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203259
Company: HETERO LABS LTD V

Products on ANDA 203259

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 203259

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/05/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/05/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203259

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

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