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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077337
Company: TEVA

Products on ANDA 077337

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	500MG;EQ 2MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	500MG;EQ 4MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	1GM;EQ 2MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	1GM;EQ 4MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	500MG;EQ 1MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077337

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2017	ORIG-2	Approval			Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/077337Orig1s000lbl.pdf
05/07/2014	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077337Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077337Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/077337Orig1s000ltr.pdf

Labels for ANDA 077337

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2017	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/077337Orig1s000lbl.pdf
05/07/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077337Orig1s000lbl.pdf

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