Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009489
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PATHILON TRIDIHEXETHYL CHLORIDE 25MG 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
09/15/1954 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
11/07/1991 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/09/1990 SUPPL-24 Labeling

Label is not available on this site.

03/27/1989 SUPPL-23 Labeling

Label is not available on this site.

09/28/1988 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/16/1987 SUPPL-21 Labeling

Label is not available on this site.

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