Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014122
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROTOPAM CHLORIDE PRALIDOXIME CHLORIDE 500MG 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
03/12/1964 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/24/1987 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/1985 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1985 SUPPL-14 Labeling

Label is not available on this site.

05/20/1985 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1979 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/01/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/11/1974 SUPPL-9

Label is not available on this site.

06/27/1974 SUPPL-8

Label is not available on this site.

11/08/1974 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

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