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FDA ANDA · ANDA083722

PHYTONADIONE

Sponsor: INTL MEDICATION

APPLICATION
ANDA083722
TYPE
ANDA
ORIGINAL APPROVAL
1976-03-01
LATEST ACTION
2023-10-23
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PHYTONADIONE · ReferencePrescription
PHYTONADIONE 1MG/0.5ML · INJECTABLE · INJECTION

Approval history

2023-10-23Manufacturing (CMC) · Supplement 34 · unknown — Letter ↗AP
2023-10-23Labeling · Supplement 29 · standard — Letter ↗AP
2023-10-23Labeling · Supplement 31 · standard — Letter ↗AP
2003-04-18Labeling · Supplement 23AP
2002-03-06Labeling · Supplement 21AP
2001-01-04Manufacturing (CMC) · Supplement 20AP
2000-07-11Manufacturing (CMC) · Supplement 5AP
1998-01-14Manufacturing (CMC) · Supplement 15AP
1995-09-19Manufacturing (CMC) · Supplement 19AP
1994-11-10Labeling · Supplement 18AP
1994-06-17Manufacturing (CMC) · Supplement 16AP
1994-02-03Labeling · Supplement 14AP
1993-10-29Manufacturing (CMC) · Supplement 13AP
1993-08-30Manufacturing (CMC) · Supplement 12AP
1992-12-09Labeling · Supplement 11 — Review ↗AP
1987-08-05Manufacturing (CMC) · Supplement 9 — Review ↗AP
1976-03-01OriginalAP
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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