Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017736
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAXIPAM HALAZEPAM 20MG TABLET;ORAL Discontinued None No No
PAXIPAM HALAZEPAM 40MG 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
09/24/1981 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
04/04/1989 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1984 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/11/1984 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/06/1982 SUPPL-3 Labeling

Label is not available on this site.

12/21/1981 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

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