Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013264
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROMOX QUINETHAZONE 50MG TABLET;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
04/10/1963 ORIG-1 Approval Type 1 - New Molecular Entity 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
07/15/1987 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/15/1983 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/21/1982 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1980 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1978 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1978 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1978 SUPPL-20 Labeling

Label is not available on this site.

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