Apomorphine Cartridge

Brand(s)
Apokyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ipsen Biopharmaceuticals, Inc. (2011-01-12)
Oldest Current Product
2004-07-02
License(s)
NDA
RxNORM
CARTRIDGE\APOMORPHINE
FDAOB
SUBCUTANEOUS\INJECTION\APOMORPHINE HYDROCHLORIDE
SPL Active
SUBCUTANEOUS\INJECTION\APOMORPHINE HYDROCHLORIDE
SPL Moiety
SUBCUTANEOUS\INJECTION\APOMORPHINE

product(s) by strength(s)

3 ml apomorphine hydrochloride 10 mg/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1150540211ApokynNDAIpsen Biopharmaceuticals, Inc.2004-07-02APOMORPHINE HYDROCHLORIDESUBCUTANEOUSINJECTIONNDA021264ab5d4084-3121-4043-bc88-a77c5277bc35

application(s)

#idtitleapplicantapprovedapproved drug
1NDA021264APOKYNUS WORLDMEDS LLC2004-04-20NDA021264_001, NDA021264_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021264_001discontinuedAPOMORPHINE HYDROCHLORIDE (20MG/2ML)SUBCUTANEOUSINJECTIONFalse2004-04-20APOKYN
2NDA021264_002RXAPOMORPHINE HYDROCHLORIDE (30MG/3ML)SUBCUTANEOUSINJECTIONTrue2004-04-20APOKYN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13235535d-9ef9-4657-8b2a-176a807d091c (view SPL)These highlights do not include all the information needed to use APOKYN safely and effectively. See full prescribing information for APOKYN. APOKYN (apomorphine hydrochloride injection) For Subcutaneous Use Only Initial U.S. Approval: 2004prescriptionHuman PrescriptionUs Worldmeds, LlcMANUFACTURE2015-06-124275050004
2ab5d4084-3121-4043-bc88-a77c5277bc35 (view SPL)APOKYN apomorphine hydrochloride injection 10 mg/mLprescriptionHuman PrescriptionIpsen Biopharmaceuticals, Inc.MANUFACTURE2011-01-128150540211

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