← FDA DRUG APPROVALS

FDA NDA · NDA011961

MARPLAN

isocarboxazid

Sponsor: LIFSA DRUGS

APPLICATION
NDA011961
TYPE
NDA
ORIGINAL APPROVAL
1959-07-01
LATEST ACTION
2018-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MARPLAN · ReferencePrescription
ISOCARBOXAZID 10MG · TABLET · ORAL

Approval history

2018-11-08Labeling · Supplement 45 · standard — Label ↗AP
2016-11-02Manufacturing (CMC) · Supplement 44 · standardAP
2007-08-10Labeling · Supplement 39 · standard — Letter ↗AP
2007-02-12Manufacturing (CMC) · Supplement 38AP
2005-01-12Labeling · Supplement 35 · standard — Letter ↗AP
2001-10-25Manufacturing (CMC) · Supplement 34 · standardAP
2000-06-23Labeling · Supplement 33 · standardAP
1998-08-19Manufacturing (CMC) · Supplement 25 · standardAP
1998-08-18Efficacy · Supplement 17 — Label ↗AP
1993-06-16Manufacturing (CMC) · Supplement 31 · standardAP
1959-07-01Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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