Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011838
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOFRANIL IMIPRAMINE HYDROCHLORIDE 12.5MG/ML INJECTABLE;INJECTION 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
10/02/1959 ORIG-1 Approval Type 3 - New Dosage Form 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
09/17/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/08/1992 SUPPL-32 Labeling

Label is not available on this site.

12/24/1992 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1985 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1985 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1985 SUPPL-27 Labeling

Label is not available on this site.

10/30/1984 SUPPL-26 Labeling

Label is not available on this site.

05/01/1984 SUPPL-25 Labeling

Label is not available on this site.

06/07/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/20/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1980 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/01/1978 SUPPL-20 Labeling

Label is not available on this site.

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