Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010796
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HARMONYL DESERPIDINE 0.1MG TABLET;ORAL Discontinued None No No
HARMONYL DESERPIDINE 0.25MG 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
04/19/1957 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
03/05/1984 SUPPL-13 Labeling

Label is not available on this site.

12/15/1983 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/25/1991 SUPPL-11 Labeling

Label is not available on this site.

07/16/1982 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/16/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1980 SUPPL-8 Labeling

Label is not available on this site.

03/13/2009 SUPPL-7 Labeling

Label is not available on this site.

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