Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078119
Company: CIPLA

Products on ANDA 078119

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078119

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078119s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2024	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
12/12/2019	SUPPL-25	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078119

ABACAVIR SULFATE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	077844	AUROBINDO PHARMA LTD
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	091050	CHARTWELL RX
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	078119	CIPLA
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	091560	HETERO LABS LTD III
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	091294	MYLAN PHARMS INC