Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076801
Company: MYLAN PHARMS INC

• Other Important Information from FDA

Products on ANDA 076801

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET;ORAL	Discontinued	None	No	No
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Discontinued	None	No	No
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076801Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2018	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/29/2018	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/21/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.