Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077950
Company: AUROBINDO PHARMA LTD

Products on ANDA 077950

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077950

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077950s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/16/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077950

ABACAVIR SULFATE

SOLUTION;ORAL; EQ 20MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	077950	AUROBINDO PHARMA LTD
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	201107	HETERO LABS LTD III
ZIAGEN	ABACAVIR SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	Yes	AA	020978	VIIV HLTHCARE