Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011721
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEPTAZANE METHAZOLAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
NEPTAZANE METHAZOLAMIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
01/26/1959 ORIG-1 Approval Type 3 - New Dosage Form 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
01/05/1999 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/12/1992 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1991 SUPPL-25 Labeling

Label is not available on this site.

03/04/1988 SUPPL-23 Labeling

Label is not available on this site.

11/25/1991 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/13/2009 SUPPL-18 Labeling

Label is not available on this site.

11/25/1991 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1991 SUPPL-15 Efficacy-New Indication

Label is not available on this site.

03/13/2009 SUPPL-12 Labeling

Label is not available on this site.

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