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FDA NDA · NDA003444

ERGOCALCIFEROL

Sponsor: ESJAY PHARMA

APPLICATION
NDA003444
TYPE
NDA
ORIGINAL APPROVAL
1941-01-11
LATEST ACTION
2003-11-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DRISDOL · ReferencePrescription
ERGOCALCIFEROL 50,000 IU · CAPSULE · ORAL

Approval history

2003-11-20Labeling · Supplement 20 · standard — Letter ↗AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1990-03-14Manufacturing (CMC) · Supplement 18AP
1988-09-14Manufacturing (CMC) · Supplement 17AP
1986-04-17Labeling · Supplement 16AP
1985-03-11Labeling · Supplement 15AP
1985-03-11Labeling · Supplement 13AP
1980-07-07Labeling · Supplement 12AP
1978-01-19Labeling · Supplement 10AP
1976-12-07Labeling · Supplement 8AP
1976-12-07Labeling · Supplement 9AP
1976-06-22Labeling · Supplement 7AP
1976-03-04Manufacturing (CMC) · Supplement 6AP
1975-06-19Labeling · Supplement 5AP
1941-01-11UNKNOWN · 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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