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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077464
Company: AUROBINDO PHARMA

Products on ANDA 077464

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2016	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077464TA_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077464s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/26/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/26/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077464

LAMIVUDINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPIVIR	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	Yes	AB	020564	VIIV HLTHCARE
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	091606	APOTEX
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	077464	AUROBINDO PHARMA
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	203586	BRECKENRIDGE
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	077221	CIPLA
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	203277	HETERO LABS LTD V
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	205217	LUPIN LTD
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	090198	MACLEODS PHARMS LTD
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	090457	STRIDES PHARMA
LAMIVUDINE	LAMIVUDINE	150MG	TABLET;ORAL	Prescription	No	AB	206974	UPSHER SMITH LABS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPIVIR	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	Yes	AB	020564	VIIV HLTHCARE
LAMIVUDINE	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	091606	APOTEX
LAMIVUDINE	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	077464	AUROBINDO PHARMA
LAMIVUDINE	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	077221	CIPLA
LAMIVUDINE	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	203277	HETERO LABS LTD V
LAMIVUDINE	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	205217	LUPIN LTD
LAMIVUDINE	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	090198	MACLEODS PHARMS LTD
LAMIVUDINE	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	090457	STRIDES PHARMA
LAMIVUDINE	LAMIVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	206974	UPSHER SMITH LABS

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