carbinoxamine Oral Solution

Brand(s)
Arbinoxa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Breckenridge Pharmaceutical, Inc. (2015-10-31)
Oldest Current Product
2003-04-25
License(s)
ANDA
RxNORM
ORAL SOLUTION\CARBINOXAMINE
FDAOB
ORAL\SOLUTION\CARBINOXAMINE MALEATE
SPL Active
ORAL\SOLUTION\CARBINOXAMINE MALEATE
ORAL\SYRUP\CARBINOXAMINE MALEATE
SPL Moiety
ORAL\SOLUTION\CARBINOXAMINE
ORAL\SYRUP\CARBINOXAMINE

product(s) by strength(s)

carbinoxamine maleate 0.8 mg/ml oral solution

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1519910334Breckenridge Pharmaceutical, Inc.CARBINOXAMINE MALEATEORALSYRUP1edca669-8879-408a-b09c-259e363dd95c

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1466720644ANDAMikart, Inc.2003-04-25CARBINOXAMINE MALEATEORALSYRUPANDA040458748c233b-6ab9-42d0-89ab-e7ead30f7947
2637170871ArbinoxaANDAHawthorn Pharmaceutical, Inc.2011-04-01CARBINOXAMINE MALEATEORALSOLUTIONANDA090418040d6792-21fe-44cc-a441-b9693178b3b5
3643760612ANDABoca Pharmacal, Llc2008-02-26CARBINOXAMINE MALEATEORALSOLUTIONANDA0408141741b4f2-af49-43fe-8319-7b8a38fa25d2

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA040458CARBINOXAMINE MALEATEMIKART INC2003-04-25ANDA040458_001
2ANDA040814CARBINOXAMINE MALEATEVINTAGE PHARMACEUTICALS2008-02-26ANDA040814_001
3ANDA090418CARBINOXAMINE MALEATECYPRESS PHARMACEUTICAL INC2010-05-04ANDA090418_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040458_001RXCARBINOXAMINE MALEATE (4MG/5ML)ORALSOLUTIONTrueAA2003-04-25CARBINOXAMINE MALEATE
2ANDA040814_001RXCARBINOXAMINE MALEATE (4MG/5ML)ORALSOLUTIONFalseAA2008-02-26CARBINOXAMINE MALEATE
3ANDA090418_001RXCARBINOXAMINE MALEATE (4MG/5ML)ORALSOLUTIONFalseAA2010-05-04CARBINOXAMINE MALEATE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1040d6792-21fe-44cc-a441-b9693178b3b5 (view SPL)Arbinoxa (Carbinoxamine Maleate) Oral Solution [Hawthorn Pharmaceuticals, Inc] Rx onlyprescriptionHuman PrescriptionHawthorn Pharmaceutical, Inc.2012-06-153637170871
21741b4f2-af49-43fe-8319-7b8a38fa25d2 (view SPL)Carbinoxamine Maleate Tablets USP, 4mgprescriptionHuman PrescriptionBoca Pharmacal, Llc2013-09-103643760612, 643760605carbinoxamine Oral Tablet
31edca669-8879-408a-b09c-259e363dd95c (view SPL)prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.2015-10-312519910334, 519910333carbinoxamine Oral Tablet
4748c233b-6ab9-42d0-89ab-e7ead30f7947 (view SPL)prescriptionHuman PrescriptionMikart, Inc.2015-08-101466720644, 466720191carbinoxamine Oral Tablet

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