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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091294
Company: MYLAN PHARMS INC

Products on ANDA 091294

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 091294

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2012	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091294s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/091294_Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2023	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/11/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/11/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/11/2015	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 091294

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	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
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	091050	STRIDES PHARMA

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