Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006920
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIPLE SULFAS TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) 167MG;167MG;167MG TABLET;ORAL Discontinued None No No
TRIPLE SULFAS TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) 167MG/5ML;167MG/5ML;167MG/5ML SUSPENSION;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
08/16/1949 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
04/17/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1977 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1977 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

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