Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013428
Company: ENDO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALPIN 50 ANISOTROPINE METHYLBROMIDE 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
11/23/1962 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
07/02/1986 SUPPL-31 Labeling

Label is not available on this site.

09/23/1983 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/11/1982 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/25/1979 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/16/1978 SUPPL-26 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/21/1978 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1978 SUPPL-24 Labeling

Label is not available on this site.

09/03/1976 SUPPL-21 Efficacy

Label is not available on this site.

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