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FDA NDA · NDA006823

AQUASOL A PARENTERAL

water-miscible retinyl palmitate

Sponsor: CASPER PHARMA LLC

APPLICATION
NDA006823
TYPE
NDA
ORIGINAL APPROVAL
1949-05-18
LATEST ACTION
2015-09-18
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AQUASOL A · ReferencePrescription
VITAMIN A PALMITATE EQ 50,000 UNITS BASE/ML · INJECTABLE · INJECTION

Approval history

2015-09-18Manufacturing (CMC) · Supplement 19AP
2014-11-11Manufacturing (CMC) · Supplement 18AP
2000-06-09Labeling · Supplement 14 · standardAP
1999-12-01Manufacturing (CMC) · Supplement 16AP
1998-04-27Manufacturing (CMC) · Supplement 15AP
1993-02-02Manufacturing (CMC) · Supplement 13AP
1990-12-07Manufacturing (CMC) · Supplement 12AP
1989-07-21Labeling · Supplement 11AP
1984-09-19Labeling · Supplement 8AP
1984-09-19Labeling · Supplement 9AP
1983-10-03Labeling · Supplement 6AP
1982-04-20Labeling · Supplement 5AP
1980-01-30Labeling · Supplement 4AP
1949-05-18UNKNOWN · Original · unknownAP
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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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