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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091606
Company: APOTEX

Products on ANDA 091606

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 091606

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/2011	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
10/03/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/03/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/03/2019	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/03/2019	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/31/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/31/2015	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/31/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/31/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/31/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091606

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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