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FDA NDA · NDA012223

AQUAMEPHYTON

Sponsor: PAI HOLDINGS PHARM

APPLICATION
NDA012223
TYPE
NDA
ORIGINAL APPROVAL
1960-06-28
LATEST ACTION
2018-11-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AQUAMEPHYTON · ReferenceDiscontinued
PHYTONADIONE 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
AQUAMEPHYTON · ReferenceDiscontinued
PHYTONADIONE 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2018-11-23Labeling · Supplement 42 · standard — Label ↗AP
2018-03-07Labeling · Supplement 41 · standard — Label ↗AP
2017-05-25Labeling · Supplement 40 · standard — Label ↗AP
2003-06-04Labeling · Supplement 39 · standard — Letter ↗AP
2003-02-27Labeling · Supplement 38 · standard — Letter ↗AP
2001-08-16Manufacturing (CMC) · Supplement 37 · standardAP
2001-05-18Labeling · Supplement 36 · standard — Letter ↗AP
1998-07-14Manufacturing (CMC) · Supplement 35 · standardAP
1998-05-28Manufacturing (CMC) · Supplement 34 · standardAP
1997-01-14Manufacturing (CMC) · Supplement 33 · standardAP
1996-12-06Manufacturing (CMC) · Supplement 32 · standardAP
1996-12-06Manufacturing (CMC) · Supplement 31 · standardAP
1996-06-25Manufacturing (CMC) · Supplement 30 · standardAP
1995-12-05Manufacturing (CMC) · Supplement 29 · standardAP
1995-06-08Manufacturing (CMC) · Supplement 28 · standardAP
1995-04-24Labeling · Supplement 27 · standardAP
1991-06-28Labeling · Supplement 26AP
1990-04-26Labeling · Supplement 25AP
1986-08-19Labeling · Supplement 21AP
1985-08-27Manufacturing (CMC) · Supplement 24 · standardAP
1984-10-11Manufacturing (CMC) · Supplement 23 · standardAP
1982-08-18Labeling · Supplement 22AP
1981-11-03Manufacturing (CMC) · Supplement 19 · standardAP
1981-07-14Manufacturing (CMC) · Supplement 20 · standardAP
1980-11-28Manufacturing (CMC) · Supplement 18 · standardAP
1979-09-18Manufacturing (CMC) · Supplement 17 · standardAP
1976-09-01Manufacturing (CMC) · Supplement 16 · standardAP
1960-06-28Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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