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): 091144
Company: CIPLA

Products on ANDA 091144

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091144

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091144s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2023	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/07/2023	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/25/2019	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/25/2019	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 091144

ABACAVIR SULFATE AND LAMIVUDINE

TABLET;ORAL; EQ 600MG BASE;300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	090159	AUROBINDO PHARMA LTD
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	204990	CHARTWELL RX
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	091144	CIPLA
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	216332	LAURUS

Top