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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078023
Company: WATSON LABS

Products on ANDA 078023

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROSIGLITAZONE	ROSIGLITAZONE MALEATE	2MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
ROSIGLITAZONE	ROSIGLITAZONE MALEATE	4MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
ROSIGLITAZONE	ROSIGLITAZONE MALEATE	8MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078023

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2007	ORIG-1	Tentative Approval				Label is not available on this site.

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