17-alpha-Hydroxyprogesterone Injectable Solution

Brand(s)
Makena
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ther-Rx Corporation (2015-02-28)
Oldest Current Product
2011-02-03
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\17-ALPHA-HYDROXYPROGESTERONE
FDAOB
INTRAMUSCULAR\SOLUTION\HYDROXYPROGESTERONE CAPROATE
SPL Active
INTRAMUSCULAR\INJECTION\HYDROXYPROGESTERONE CAPROATE
SPL Moiety
INTRAMUSCULAR\INJECTION\HYDROXYPROGESTERONE

product(s) by strength(s)

hydroxyprogesterone caproate (usp) 250 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1640110243MakenaNDATher-Rx Corporation2011-02-03HYDROXYPROGESTERONE CAPROATEINTRAMUSCULARINJECTIONNDA021945a1998c1d-8337-4f00-8dcb-af3b54d39b77

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA021945MAKENALUMARA HEALTH INC2011-02-03ORPHAN DRUG EXCLUSIVITY [2018-02-03]NDA021945_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021945_001RXHYDROXYPROGESTERONE CAPROATE (1250MG/5ML)INTRAMUSCULARSOLUTIONTrue2011-02-03MAKENA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a1998c1d-8337-4f00-8dcb-af3b54d39b77 (view SPL)These highlights do not include all the information needed to use MAKENA safely and effectively. See full prescribing information for MAKENA. MAKENA (hydroxyprogesterone caproate injection) for intramuscular use. Initial U.S. Approval: 1956prescriptionHuman PrescriptionTher-Rx CorporationANALYSIS, MANUFACTURE2015-02-288640110243

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