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FDA NDA · NDA017808

MIACALCIN

calcitonin salmon

Sponsor: MYLAN IRELAND LTD

APPLICATION
NDA017808
TYPE
NDA
ORIGINAL APPROVAL
1986-07-03
LATEST ACTION
2017-09-11
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

MIACALCIN · ReferenceDiscontinued
CALCITONIN SALMON 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
MIACALCIN · ReferencePrescription
CALCITONIN SALMON 200 IU/ML · INJECTABLE · INJECTION

Approval history

2017-09-11Labeling · Supplement 37 · standard — Label ↗AP
2015-02-02Labeling · Supplement 36 · standard — Letter ↗AP
2014-03-11Labeling · Supplement 35 · standard — Letter ↗AP
2013-02-19Manufacturing (CMC) · Supplement 33 · standardAP
2012-04-18Labeling · Supplement 34 · standard — Label ↗AP
2009-10-30Labeling · Supplement 30 · standard — Label ↗AP
2003-06-03Labeling · Supplement 24 · standard — Letter ↗AP
2002-02-12Manufacturing (CMC) · Supplement 22 · standardAP
2001-11-02Manufacturing (CMC) · Supplement 20 · standardAP
1999-07-23Manufacturing (CMC) · Supplement 18 · standardAP
1999-05-26Manufacturing (CMC) · Supplement 17 · standardAP
1999-01-13Manufacturing (CMC) · Supplement 16 · standardAP
1998-12-24Manufacturing (CMC) · Supplement 15 · standardAP
1997-08-01Manufacturing (CMC) · Supplement 13 · standardAP
1997-07-14Labeling · Supplement 14 · standard — Review ↗AP
1997-01-02Manufacturing (CMC) · Supplement 12 · standardAP
1996-08-14Manufacturing (CMC) · Supplement 11 · standardAP
1995-06-09Manufacturing (CMC) · Supplement 10 · standardAP
1994-07-22Manufacturing (CMC) · Supplement 5 · standardAP
1993-03-26Labeling · Supplement 3AP
1993-02-22Manufacturing (CMC) · Supplement 8 · standardAP
1992-08-05Manufacturing (CMC) · Supplement 9 · standardAP
1992-06-26Manufacturing (CMC) · Supplement 4 · standardAP
1992-06-10Labeling · Supplement 6AP
1992-06-01Labeling · Supplement 7AP
1991-10-03Labeling · Supplement 2AP
1991-03-29Manufacturing (CMC) · Supplement 1 · standardAP
1986-07-03Type 5 - New Formulation or New Manufacturer · 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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