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FDA ANDA · ANDA080704

ERGOCALCIFEROL

Sponsor: BIONPHARMA

APPLICATION
ANDA080704
TYPE
ANDA
ORIGINAL APPROVAL
1978-10-16
LATEST ACTION
2008-07-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

VITAMIN DPrescription
ERGOCALCIFEROL 50,000 IU · CAPSULE · ORAL

Approval history

2008-07-24Labeling · Supplement 43AP
2001-10-24Manufacturing (CMC) · Supplement 39AP
2001-10-24Manufacturing (CMC) · Supplement 37AP
2001-10-24Labeling · Supplement 41AP
2001-10-24Manufacturing (CMC) · Supplement 38AP
2001-10-24Manufacturing (CMC) · Supplement 40AP
1998-09-09Manufacturing (CMC) · Supplement 36AP
1997-01-16Manufacturing (CMC) · Supplement 30AP
1996-08-28Manufacturing (CMC) · Supplement 33AP
1996-08-28Manufacturing (CMC) · Supplement 34AP
1996-08-28Manufacturing (CMC) · Supplement 32AP
1995-05-31Manufacturing (CMC) · Supplement 31AP
1995-01-24Manufacturing (CMC) · Supplement 29AP
1995-01-24Manufacturing (CMC) · Supplement 28AP
1989-03-24Labeling · Supplement 27AP
1985-03-22Manufacturing (CMC) · Supplement 16AP
1985-03-22Manufacturing (CMC) · Supplement 22AP
1985-03-22Manufacturing (CMC) · Supplement 20AP
1985-03-22Manufacturing (CMC) · Supplement 19AP
1985-03-22Manufacturing (CMC) · Supplement 17AP
1985-03-22Manufacturing (CMC) · Supplement 23AP
1985-03-22Manufacturing (CMC) · Supplement 15AP
1985-03-22Manufacturing (CMC) · Supplement 21AP
1985-03-22Manufacturing (CMC) · Supplement 18AP
1984-03-08Manufacturing (CMC) · Supplement 12AP
1978-10-16OriginalAP
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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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