← FDA DRUG APPROVALS

FDA NDA · NDA012342

TRANYLCYPROMINE SULFATE

Sponsor: ADVANZ PHARMA

APPLICATION
NDA012342
TYPE
NDA
ORIGINAL APPROVAL
1961-02-21
LATEST ACTION
2018-01-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PARNATE · ReferencePrescription
TRANYLCYPROMINE SULFATE EQ 10MG BASE · TABLET · ORAL

Approval history

2018-01-04Labeling · Supplement 64 · standard — Label ↗AP
2010-05-14Labeling · Supplement 63 · unknown — Letter ↗AP
2009-11-27Labeling · Supplement 61 · standard — Label ↗AP
2007-08-02Labeling · Supplement 59 · standard — Letter ↗AP
2006-01-23Labeling · Supplement 57 · standard — Letter ↗AP
2006-01-23Labeling · Supplement 56 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 55 · standard — Letter ↗AP
2001-10-23Labeling · Supplement 53 · standardAP
2001-03-15Labeling · Supplement 40 — Letter ↗AP
2001-03-15Labeling · Supplement 39 — Letter ↗AP
2001-03-15Labeling · Supplement 37 — Letter ↗AP
2001-03-15Labeling · Supplement 51 · standard — Letter ↗AP
2001-03-15Labeling · Supplement 48 — Letter ↗AP
2001-03-15Labeling · Supplement 46 — Letter ↗AP
2001-03-15Labeling · Supplement 44 — Letter ↗AP
1997-07-14Manufacturing (CMC) · Supplement 52 · priorityAP
1988-02-24Labeling · Supplement 36AP
1984-03-22Efficacy · Supplement 28AP
1984-03-22Efficacy · Supplement 31AP
1981-04-06Labeling · Supplement 26AP
1980-05-20Labeling · Supplement 22AP
1978-06-20Labeling · Supplement 17AP
1961-02-21Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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