Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202912
Company: LUPIN LTD

Products on ANDA 202912

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202912

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/05/2013	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202912Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2022	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/22/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/22/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/22/2020	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/22/2020	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202912

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET;ORAL	Prescription	No	AB	202912	LUPIN LTD