Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009182
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GANTRISIN SULFISOXAZOLE ACETYL EQ 500MG BASE/5ML SYRUP;ORAL Discontinued None No No
GANTRISIN PEDIATRIC SULFISOXAZOLE ACETYL EQ 500MG BASE/5ML SUSPENSION;ORAL Discontinued None No No
LIPO GANTRISIN SULFISOXAZOLE ACETYL EQ 1GM BASE/5ML EMULSION;ORAL Discontinued None No 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
12/04/1953 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/1996 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1995 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1993 SUPPL-17 Labeling

Label is not available on this site.

05/25/1982 SUPPL-16 Labeling

Label is not available on this site.

01/27/1978 SUPPL-14 Labeling

Label is not available on this site.

12/22/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1975 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

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