← FDA DRUG APPROVALS

FDA NDA · NDA011909

PHENELZINE SULFATE

Sponsor: PARKE DAVIS

APPLICATION
NDA011909
TYPE
NDA
ORIGINAL APPROVAL
1961-06-09
LATEST ACTION
2007-08-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NARDIL · ReferencePrescription
PHENELZINE SULFATE EQ 15MG BASE · TABLET · ORAL

Approval history

2007-08-02Labeling · Supplement 38 · standard — Letter ↗AP
2007-02-06Manufacturing (CMC) · Supplement 36 — Label ↗AP
2005-02-18Labeling · Supplement 35 · standard — Letter ↗AP
2003-09-02Labeling · Supplement 33 · standard — Label ↗AP
2002-01-03Labeling · Supplement 30 · standard — Review ↗AP
1998-02-25Manufacturing (CMC) · Supplement 28 · standardAP
1998-02-24Manufacturing (CMC) · Supplement 27 · standardAP
1994-07-14Manufacturing (CMC) · Supplement 23 · standardAP
1986-08-27Manufacturing (CMC) · Supplement 8 · standardAP
1986-08-27Manufacturing (CMC) · Supplement 10 · standardAP
1985-03-28Labeling · Supplement 13AP
1982-11-03Labeling · Supplement 12AP
1978-03-08Labeling · Supplement 9AP
1961-06-09Type 1 - New Molecular Entity · Original · standard — Medication Guide ↗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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