FDA NDA · NDA011838

TOFRANIL

Sponsor: NOVARTIS

APPLICATION

NDA011838

TYPE

NDA

ORIGINAL APPROVAL

1959-10-02

LATEST ACTION

1998-09-17

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

TOFRANILDiscontinued

IMIPRAMINE HYDROCHLORIDE 12.5MG/ML · INJECTABLE · INJECTION

1998-09-17Manufacturing (CMC) · Supplement 34 · standardAP

1992-12-24Manufacturing (CMC) · Supplement 31 · standardAP

1992-12-08Labeling · Supplement 32AP

1985-11-27Manufacturing (CMC) · Supplement 29 · standardAP

1985-05-13Manufacturing (CMC) · Supplement 28 · standardAP

1985-04-29Labeling · Supplement 27AP

1984-10-30Labeling · Supplement 26AP

1984-05-01Labeling · Supplement 25AP

1983-06-07Manufacturing (CMC) · Supplement 23 · standardAP

1981-03-20Manufacturing (CMC) · Supplement 22 · standardAP

1980-03-31Manufacturing (CMC) · Supplement 21 · standardAP

1978-12-01Labeling · Supplement 20AP

1959-10-02Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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