carbinoxamine Oral Tablet

Brand(s)
Arbinoxa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Breckenridge Pharmaceutical, Inc. (2015-10-31)
Oldest Current Product
2003-03-19
License(s)
ANDA
RxNORM
ORAL TABLET\CARBINOXAMINE
FDAOB
ORAL\TABLET\CARBINOXAMINE MALEATE
SPL Active
ORAL\TABLET\CARBINOXAMINE MALEATE
SPL Moiety
ORAL\TABLET\CARBINOXAMINE

product(s) by strength(s)

carbinoxamine maleate 4 mg oral tablet

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1519910333Breckenridge Pharmaceutical, Inc.CARBINOXAMINE MALEATEORALTABLET1edca669-8879-408a-b09c-259e363dd95c

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1445230825ANDABiocomp Pharma, Inc.2011-05-27CARBINOXAMINE MALEATEORALTABLETANDA09075614266e97-674b-b6a9-37a2-a955f0a01c4f
2466720191ANDAMikart, Inc.2003-03-19CARBINOXAMINE MALEATEORALTABLETANDA040442748c233b-6ab9-42d0-89ab-e7ead30f7947
3602580870ANDACypress Pharmaceutical, Inc.2010-08-23CARBINOXAMINE MALEATEORALTABLETANDA0904174eb6ad42-660d-4cf0-b788-cd42828ac54a
4637170870ArbinoxaANDAHawthorn Pharmaceutical, Inc.2010-08-23CARBINOXAMINE MALEATEORALTABLETANDA0904173f4f633c-5c5d-4d52-abb8-dfa2896b40d2
5643760605ANDABoca Pharmacal, Llc2008-05-30CARBINOXAMINE MALEATEORALTABLETANDA0406391741b4f2-af49-43fe-8319-7b8a38fa25d2

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040442CARBINOXAMINE MALEATEMIKART INC2003-03-19ANDA040442_001
2ANDA040639CARBINOXAMINE MALEATEVINTAGE PHARMACEUTICALS2008-05-30ANDA040639_002
3ANDA090417CARBINOXAMINE MALEATECYPRESS PHARMACEUTICAL INC2010-08-23ANDA090417_001
4ANDA090435CARBINOXAMINE MALEATEINVAGEN PHARMACEUTICALS INC2010-04-15ANDA090435_001
5ANDA090756CARBINOXAMINE MALEATEMISSION PHARMACAL CO2011-05-27ANDA090756_001
6NDA008915CLISTINTrueORTHO MCNEIL PHARMACEUTICAL INCNDA008915_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040442_001RXCARBINOXAMINE MALEATE (4MG)ORALTABLETTrueAA2003-03-19CARBINOXAMINE MALEATE
2ANDA040639_002RXCARBINOXAMINE MALEATE (4MG)ORALTABLETFalseAA2008-05-30CARBINOXAMINE MALEATE
3ANDA090417_001RXCARBINOXAMINE MALEATE (4MG)ORALTABLETFalseAA2010-08-23CARBINOXAMINE MALEATE
4ANDA090435_001RXCARBINOXAMINE MALEATE (4MG)ORALTABLETFalseAA2010-04-15CARBINOXAMINE MALEATE
5ANDA090756_001RXCARBINOXAMINE MALEATE (4MG)ORALTABLETFalseAA2011-05-27CARBINOXAMINE MALEATE
6NDA008915_001discontinuedCARBINOXAMINE MALEATE (4MG)ORALTABLETFalseCLISTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
114266e97-674b-b6a9-37a2-a955f0a01c4f (view SPL)Carbinoxamine Maleate Tablets, USP 4 mgprescriptionHuman PrescriptionBiocomp Pharma, Inc.MANUFACTURE2015-08-311445230825
21741b4f2-af49-43fe-8319-7b8a38fa25d2 (view SPL)Carbinoxamine Maleate Tablets USP, 4mgprescriptionHuman PrescriptionBoca Pharmacal, Llc2013-09-103643760605, 643760612carbinoxamine Oral Solution
31edca669-8879-408a-b09c-259e363dd95c (view SPL)prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.2015-10-312519910333, 519910334carbinoxamine Oral Solution
43f4f633c-5c5d-4d52-abb8-dfa2896b40d2 (view SPL)Arbinoxa Tablets(Carbinoxamine Maleate Tablets, USP) 4 mgRx onlyNDC 63717-870-01prescriptionHuman PrescriptionHawthorn Pharmaceutical, Inc.2015-08-285637170870
54eb6ad42-660d-4cf0-b788-cd42828ac54a (view SPL)Carbinoxamine Maleate Tablets, USP 4 mgRx onlyNDC 60258-870-01prescriptionHuman PrescriptionCypress Pharmaceutical, Inc.2012-06-153602580870
6748c233b-6ab9-42d0-89ab-e7ead30f7947 (view SPL)prescriptionHuman PrescriptionMikart, Inc.2015-08-101466720191, 466720644carbinoxamine Oral Solution

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