Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017895
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JANIMINE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
JANIMINE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None No No
JANIMINE IMIPRAMINE HYDROCHLORIDE 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
11/15/1974 ORIG-1 Approval Type 6 - New Indication (no longer used) 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
09/12/1988 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1987 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/13/1984 SUPPL-10 Labeling

Label is not available on this site.

03/27/1984 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1983 SUPPL-8 Labeling

Label is not available on this site.

07/15/1983 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/25/1981 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/08/1977 SUPPL-4 Labeling

Label is not available on this site.

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