Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020035
Company: JANSSEN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERGAMISOL LEVAMISOLE HYDROCHLORIDE EQ 50MG BASE 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
06/18/1990 ORIG-1 Approval Type 1 - New Molecular Entity 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
12/20/1999 SUPPL-13 Labeling

Label is not available on this site.

07/16/1998 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1998 SUPPL-11 Labeling

Label is not available on this site.

05/27/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1996 SUPPL-9 Labeling

Label is not available on this site.

11/22/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/20/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/11/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/17/1993 SUPPL-5 Labeling

Label is not available on this site.

12/14/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/26/1992 SUPPL-3 Labeling

Label is not available on this site.

03/10/1992 SUPPL-2 Labeling

Label is not available on this site.

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