salmon calcitonin Injectable Solution

Brand(s)
Miacalcin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sebela Pharmaceuticals Inc. (2015-09-29)
Oldest Current Product
1986-07-03
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\SALMON CALCITONIN
FDAOB
INJECTION\INJECTION\CALCITONIN SALMON\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\CALCITONIN SALMON
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\CALCITONIN SALMON

product(s) by strength(s)

salmon calcitonin 200 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1547660149MiacalcinNDASebela Pharmaceuticals Inc.1986-07-032018-03-31CALCITONIN SALMONINTRAMUSCULARINJECTION, SOLUTIONNDA0178082a27340f-26e7-4003-b817-60de6696088b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073690CALCITONIN-SALMONTrueIGI LABORATORIES INC1995-04-14ANDA073690_001
2NDA017497CALCIMARTrueSANOFI AVENTIS US LLCNDA017497_001
3NDA017769CALCIMARTrueSANOFI AVENTIS US LLCNDA017769_001
4NDA017808MIACALCINMYLAN IRELAND LTD1986-07-03NDA017808_001, NDA017808_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA073690_001discontinuedCALCITONIN SALMON (200 IU/ML)INJECTIONFalse1995-04-14CALCITONIN-SALMON
2NDA017497_001discontinuedCALCITONIN SALMON (400 IU/VIAL)INJECTIONFalseCALCIMAR
3NDA017769_001discontinuedCALCITONIN SALMON (200 IU/ML)INJECTIONFalseCALCIMAR
4NDA017808_001discontinuedCALCITONIN SALMON (100 IU/ML)INJECTIONFalse1986-07-03MIACALCIN
5NDA017808_002RXCALCITONIN SALMON (200 IU/ML)INJECTIONTrue1991-03-29MIACALCIN

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12a27340f-26e7-4003-b817-60de6696088b (view SPL)These highlights do not include all the information needed to use MIACALCIN injection safely and effectively. See full prescribing information for MIACALCIN injection. MIACALCIN (calcitonin-salmon) injection, synthetic, for subcutaneous or intramuscular use Initial U.S. Approval: 1975prescriptionHuman PrescriptionSebela Pharmaceuticals Inc.2015-09-293547660149
2f9d5a587-e2bc-4001-987d-9b04731303cb (view SPL)These highlights do not include all the information needed to use MIACALCIN injection safely and effectively. See full prescribing information for MIACALCIN injection. MIACALCIN (calcitonin-salmon) injection, synthetic, for subcutaneous or intramuscular use Initial U.S. Approval: 1975prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-02-026000780149

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