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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019358
Company: ROCHE

Products on NDA 019358

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZO GANTRISIN	PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE	50MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019358

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/1990	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD		Label is not available on this site.

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