Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011838
Company: NOVARTIS

• Other Important Information from FDA

Products on NDA 011838

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011838

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.