← FDA DRUG APPROVALS

FDA NDA · NDA020313

MIACALCIN

Sponsor: ALLIED

APPLICATION
NDA020313
TYPE
NDA
ORIGINAL APPROVAL
1995-08-17
LATEST ACTION
2017-09-12
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

MIACALCIN · ReferenceDiscontinued
CALCITONIN SALMON 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2017-09-12Labeling · Supplement 36 · standard — Label ↗AP
2014-03-11Labeling · Supplement 34 · unknown — Label ↗AP
2014-02-27Manufacturing (CMC) · Supplement 35 · standardAP
2012-04-18Labeling · Supplement 33 · standard — Letter ↗AP
2009-10-30Labeling · Supplement 29 · standard — Label ↗AP
2006-01-06Labeling · Supplement 21 · standard — Letter ↗AP
2003-08-22Manufacturing (CMC) · Supplement 23 · standard — Review ↗AP
2002-05-10Manufacturing (CMC) · Supplement 20 · standardAP
2001-11-02Manufacturing (CMC) · Supplement 18 · standardAP
2000-07-14Manufacturing (CMC) · Supplement 17 · standardAP
1999-07-23Manufacturing (CMC) · Supplement 15 · standardAP
1999-01-13Manufacturing (CMC) · Supplement 14 · standardAP
1998-12-24Manufacturing (CMC) · Supplement 4 · standardAP
1998-12-17Manufacturing (CMC) · Supplement 12 · standardAP
1998-08-14Manufacturing (CMC) · Supplement 11 · standardAP
1998-01-12Labeling · Supplement 10 · standardAP
1997-09-15Manufacturing (CMC) · Supplement 8 · standardAP
1997-08-01Manufacturing (CMC) · Supplement 7 · standardAP
1997-04-24Manufacturing (CMC) · Supplement 6 · standardAP
1997-03-27Manufacturing (CMC) · Supplement 5 · standardAP
1997-03-07Labeling · Supplement 3 · standardAP
1996-10-22Labeling · Supplement 2 · standardAP
1995-08-17Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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