Droperidol Injectable Solution

Brand(s)
Inapsine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2011-12-22)
Oldest Current Product
1988-02-29
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DROPERIDOL
FDAOB
INJECTION\INJECTION\DROPERIDOL\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\DROPERIDOL
INTRAMUSCULAR\INJECTION\DROPERIDOL
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\DROPERIDOL
INTRAMUSCULAR\INJECTION\DROPERIDOL

product(s) by strength(s)

droperidol 2.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780010InapsineNDAAkorn1996-07-01DROPERIDOLINTRAMUSCULARINJECTIONNDA016796dbc2d9eb-eefe-454d-a8c3-55cec840d54f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091187ANDAHospira, Inc.1988-02-29DROPERIDOLINTRAMUSCULARINJECTION, SOLUTIONANDA071981b99a44df-ff38-4602-68ab-9bef1ff3af83
2005179702ANDAAmerican Regent, Inc.1990-09-30DROPERIDOLINTRAMUSCULARINJECTION, SOLUTIONANDA072123147e033d-d997-4ef6-8bb5-a9ba372590b2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840041ANDAGeneral Injecatables & Vaccines, Inc2012-10-18DROPERIDOLINTRAMUSCULARINJECTION, SOLUTION005179702ANDA07212354c9ad21-5051-4263-948a-db651b5fd05d
2551545706ANDACardinal Health1990-09-30DROPERIDOLINTRAMUSCULARINJECTION, SOLUTION005179702ANDA0721237bd2c1cf-31c0-49c7-a856-f238a46f6f1f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070992DROPERIDOLTrueABRAXIS PHARMACEUTICAL PRODUCTS1986-11-17ANDA070992_001
2ANDA070993DROPERIDOLTrueABRAXIS PHARMACEUTICAL PRODUCTS1986-11-17ANDA070993_001
3ANDA071645DROPERIDOLTrueHOSPIRA INC1988-04-07ANDA071645_001
4ANDA071750DROPERIDOLTrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1988-09-06ANDA071750_001
5ANDA071754DROPERIDOLTrueSOLOPAK LABORATORIES INC1988-09-06ANDA071754_001
6ANDA071755DROPERIDOLTrueSOLOPAK LABORATORIES INC1988-09-06ANDA071755_001
7ANDA071981DROPERIDOLHOSPIRA INC1988-02-29ANDA071981_001
8ANDA072018DROPERIDOLTrueASTRAZENECA LP1988-10-20ANDA072018_001
9ANDA072019DROPERIDOLTrueIGI LABORATORIES INC1988-10-19ANDA072019_001
10ANDA072020DROPERIDOLTrueIGI LABORATORIES INC1988-10-19ANDA072020_001
11ANDA072021DROPERIDOLTrueIGI LABORATORIES INC1988-10-19ANDA072021_001
12ANDA072123DROPERIDOLLUITPOLD PHARMACEUTICALS INC1988-10-24ANDA072123_001
13ANDA072272DROPERIDOLTrueHOSPIRA INC1995-08-31ANDA072272_001
14ANDA072335DROPERIDOLTrueLUITPOLD PHARMACEUTICALS INC1988-10-24ANDA072335_001
15ANDA073520DROPERIDOLTrueWATSON LABORATORIES INC1991-11-27ANDA073520_001
16ANDA073521DROPERIDOLTrueWATSON LABORATORIES INC1991-11-27ANDA073521_001
17ANDA073523DROPERIDOLTrueWATSON LABORATORIES INC1991-11-27ANDA073523_001
18NDA016796INAPSINEAKORN INCNDA016796_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070992_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1986-11-17DROPERIDOL
2ANDA070993_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1986-11-17DROPERIDOL
3ANDA071645_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-04-07DROPERIDOL
4ANDA071750_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-09-06DROPERIDOL
5ANDA071754_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-09-06DROPERIDOL
6ANDA071755_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-09-06DROPERIDOL
7ANDA071981_001RXDROPERIDOL (2.5MG/ML)INJECTIONFalseAP1988-02-29DROPERIDOL
8ANDA072018_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-10-20DROPERIDOL
9ANDA072019_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-10-19DROPERIDOL
10ANDA072020_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-10-19DROPERIDOL
11ANDA072021_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-10-19DROPERIDOL
12ANDA072123_001RXDROPERIDOL (2.5MG/ML)INJECTIONFalseAP1988-10-24DROPERIDOL
13ANDA072272_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1995-08-31DROPERIDOL
14ANDA072335_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1988-10-24DROPERIDOL
15ANDA073520_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1991-11-27DROPERIDOL
16ANDA073521_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1991-11-27DROPERIDOL
17ANDA073523_001discontinuedDROPERIDOL (2.5MG/ML)INJECTIONFalse1991-11-27DROPERIDOL
18NDA016796_001RXDROPERIDOL (2.5MG/ML)INJECTIONTrueAPINAPSINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1147e033d-d997-4ef6-8bb5-a9ba372590b2 (view SPL)DROPERIDOL INJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-11-113005179702
254c9ad21-5051-4263-948a-db651b5fd05d (view SPL)DROPERIDOL INJECTION, USPFor IV or IM Use OnlyRx OnlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Increlabel2012-10-181525840041
37bd2c1cf-31c0-49c7-a856-f238a46f6f1f (view SPL)DROPERIDOL INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-091551545706
4b99a44df-ff38-4602-68ab-9bef1ff3af83 (view SPL)DROPERIDOLprescriptionHuman PrescriptionHospira, Inc.2013-07-2312004091187
5dbc2d9eb-eefe-454d-a8c3-55cec840d54f (view SPL)Inapsine (Droperidol) Injection 1 mL and 2 mLprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK, STERILIZE2011-12-221174780010, 174780531

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