Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012947
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;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
04/18/1962 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
06/15/1993 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1987 SUPPL-20 Labeling

Label is not available on this site.

07/24/1987 SUPPL-19 Labeling

Label is not available on this site.

06/26/1984 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1977 SUPPL-11 Efficacy

Label is not available on this site.

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