Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019358
Company: ROCHE
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HYDROCHLORIDE; SULFISOXAZOLE 50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
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

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