Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076747
Company: ANI PHARMS

• Other Important Information from FDA

Products on ANDA 076747

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROSIGLITAZONE MALEATE	ROSIGLITAZONE MALEATE	EQ 2MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSIGLITAZONE MALEATE	ROSIGLITAZONE MALEATE	EQ 4MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSIGLITAZONE MALEATE	ROSIGLITAZONE MALEATE	EQ 8MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076747

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2013	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076747Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076747Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2014	SUPPL-1	REMS-Modified		Label is not available on this site.

Labels for ANDA 076747

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/25/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076747Orig1s000lbl.pdf