salmon calcitonin Nasal Spray

Brand(s)
Fortical, Miacalcin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2014-03-11)
Oldest Current Product
1995-08-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
NASAL SPRAY\SALMON CALCITONIN
FDAOB
NASAL\SPRAY, METERED\CALCITONIN SALMON
NASAL\SPRAY, METERED\CALCITONIN SALMON RECOMBINANT
SPL Active
NASAL\SPRAY, METERED\CALCITONIN SALMON
SPL Moiety
NASAL\SPRAY, METERED\CALCITONIN SALMON

product(s) by strength(s)

salmon calcitonin 200 unt/actuat nasal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780311MiacalcinNDANovartis Pharmaceuticals Corporation1995-08-01CALCITONIN SALMONNASALSPRAY, METEREDNDA020313e147226d-7bf3-4f72-959b-8abd6464fbcd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007816320NDA AUTHORIZED GENERICSandoz Inc1995-08-01CALCITONIN SALMONNASALSPRAY, METEREDNDA0203130614bf53-9644-47d2-b46e-8efbcd63afe6
2498840161ANDAPar Pharmaceutical Companies, Inc.2009-06-08CALCITONIN SALMONNASALSPRAY, METEREDANDA076979a6eaedb3-5c96-4859-be43-a48c9c818bc7
3605050823ANDAApotex Corp2008-12-09CALCITONIN SALMONNASALSPRAY, METEREDANDA076396c82eb602-12e1-692b-d660-f8d5b5736b54

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685499ForticalNDAPhysicians Total Care, Inc.2005-12-30CALCITONIN SALMONNASALSPRAY, METERED00245000835NDA021406e662c321-8c1b-4829-b4c9-459284f654c3
2548686323ANDAPhysicians Total Care, Inc.2011-12-09CALCITONIN SALMONNASALSPRAY, METERED498840161ANDA0769791d20ac74-4cd8-4277-9e43-79df44c26254

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076396CALCITONIN-SALMONAPOTEX INC2008-11-17ANDA076396_001
2ANDA076979CALCITONIN-SALMONPAR PHARMACEUTICAL INC2009-06-08ANDA076979_001
3NDA020313MIACALCINMYLAN IRELAND LTD1995-08-17p5759565
p5733569, NASAL ADMINISTRATION
NDA020313_002
4NDA021406FORTICALUPSHER SMITH LABORATORIES INC2005-08-12p6440392, NASAL ADMINISTRATION, SUBSTANCE
pRE40812, SUBSTANCE
pRE43580, NASAL ADMINISTRATION, SUBSTANCE
NDA021406_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076396_001RXCALCITONIN SALMON (200 IU/SPRAY)NASALSPRAY, METEREDFalseAB2008-11-17CALCITONIN-SALMON
2ANDA076979_001RXCALCITONIN SALMON (200 IU/SPRAY)NASALSPRAY, METEREDFalseAB2009-06-08CALCITONIN-SALMON
3NDA020313_002RXCALCITONIN SALMON (200 IU/SPRAY)NASALSPRAY, METEREDTrueAB1995-08-17MIACALCIN
4NDA021406_001RXCALCITONIN SALMON RECOMBINANT (200 IU/SPRAY)NASALSPRAY, METEREDTrue2005-08-12FORTICAL

patent(s)

#idexpiration dateapplication(s)
1p5733569 (view patent)2015-03-31NDA020313
2p5759565 (view patent)2015-03-31NDA020313
3p6440392 (view patent)2021-02-02NDA021406
4pRE40812 (view patent)2021-02-02NDA021406
5pRE43580 (view patent)2021-02-02NDA021406

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10614bf53-9644-47d2-b46e-8efbcd63afe6 (view SPL)These highlights do not include all the information needed to use CALCITONIN-SALMON nasal spray safely and effectively. See full prescribing information for CALCITONIN-SALMON nasal spray. CALCITONIN-SALMON nasal spray, for intranasal use Initial U.S. Approval: 1975prescriptionHuman PrescriptionSandoz Inc2014-03-115007816320
21d20ac74-4cd8-4277-9e43-79df44c26254 (view SPL)Calcitonin-SalmonNasal Spray, USPRx OnlyPrescribing InformationprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-12-121548686323
3a6eaedb3-5c96-4859-be43-a48c9c818bc7 (view SPL)Calcitonin Salmon Nasal Solution, USP (Calcitonin Salmon Nasal Spray) For Intranasal Use Only (Synthetic Origin) Rx Only Prescribing InformationprescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2012-06-159498840161
4c82eb602-12e1-692b-d660-f8d5b5736b54 (view SPL)These highlights do not include all the information needed to use Calcitonin Salmon (synthetic origin) Nasal Spray (Calcitonin Salmon Nasal Solution, USP) safely and effectively. See full prescribing information for Calcitonin Salmon (synthetic origin) Nasal Spray (Calcitonin Salmon Nasal Solution, USP). Calcitonin Salmon (synthetic origin) Nasal Spray (Calcitonin Salmon Nasal Solution, USP), for intranasal use Initial U.S. Approval: 1975prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-09-176605050823
5e147226d-7bf3-4f72-959b-8abd6464fbcd (view SPL)These highlights do not include all the information needed to use MIACALCIN nasal spray safely and effectively. See full prescribing information for MIACALCIN nasal spray. MIACALCIN (calcitonin-salmon) nasal spray, for intranasal use Initial U.S. Approval: 1975prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2014-03-115000780311
6e273664a-3f6d-4ed4-9495-3fe8338e7895 (view SPL)These highlights do not include all the information needed to use FORTICAL safely and effectively. See full prescribing information for FORTICAL. FORTICAL (calcitonin-salmon [rDNA origin]) Nasal Spray for intranasal useInitial U.S. Approval: 2005prescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, REPACK2014-07-1810002450008
7e662c321-8c1b-4829-b4c9-459284f654c3 (view SPL)FORTICAL calcitonin-salmon (rDNA origin) Nasal SprayprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-151548685499

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII