Benztropine Injectable Solution

Brand(s)
Cogentin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Oak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.) (2013-05-10)
Oldest Current Product
1959-08-05
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\BENZTROPINE
FDAOB
INJECTION\INJECTION\BENZTROPINE MESYLATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\BENZTROPINE MESYLATE
INTRAMUSCULAR\INJECTION\BENZTROPINE MESYLATE
PARENTERAL\INJECTION\BENZTROPINE MESYLATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\BENZTROPINE
INTRAMUSCULAR\INJECTION\BENZTROPINE
PARENTERAL\INJECTION\BENZTROPINE

product(s) by strength(s)

benztropine mesylate 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1764780611CogentinNDAOak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.)1959-08-05BENZTROPINE MESYLATEINTRAMUSCULARINJECTIONNDA012015b707bc17-3ab4-47a9-a83e-ebd1d384a9d8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439729ANDAWest-Ward Pharmaceutical Corp2009-09-01BENZTROPINE MESYLATEINTRAMUSCULARINJECTIONANDA09028795620f40-5ddf-41b8-80a5-f658248f26f0
2005170785ANDAAmerican Regent, Inc.2011-02-04BENZTROPINE MESYLATEINTRAMUSCULARINJECTION, SOLUTIONANDA091152633411f3-f092-4f59-84b0-6ac12a8aa013
3147890300ANDANexus Pharmaceuticals Inc2009-07-29BENZTROPINE MESYLATEPARENTERALINJECTIONANDA090233bbacbb05-2e18-4cf9-b239-6addb60b7533
4174780012NDA AUTHORIZED GENERICAkorn2012-08-08BENZTROPINE MESYLATEINTRAMUSCULARINJECTIONNDA01201557107a07-3347-4eac-8d3e-7d5e0c0a2974
5633230970ANDAApp Pharmaceuticals, Llc2011-05-31BENZTROPINE MESYLATEINTRAMUSCULARINJECTION, SOLUTIONANDA090233b03bd28e-3b44-41e4-9a7e-28b9d7975245
6683820860ANDAZydus Pharmaceuticals (Usa) Inc.2015-05-18BENZTROPINE MESYLATEINTRAMUSCULARINJECTIONANDA091525ecaeaadf-0847-4605-a205-a674f75f8bb2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1647250012NDA AUTHORIZED GENERICTya Pharmaceuticals2012-08-08BENZTROPINE MESYLATEINTRAMUSCULARINJECTION174780012NDA012015d61eae0d-a29d-45ef-bd41-07123e0c21f9

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090233BENZTROPINE MESYLATEFRESENIUS KABI USA LLC2009-07-28ANDA090233_001
2ANDA090287BENZTROPINE MESYLATEHIKMA FARMACEUTICA (PORTUGAL) SA2009-08-31ANDA090287_001
3ANDA091152BENZTROPINE MESYLATELUITPOLD PHARMACEUTICALS INC2010-03-29ANDA091152_001
4ANDA091525BENZTROPINE MESYLATENAVINTA LLC2013-02-05ANDA091525_001
5NDA012015COGENTINOAK PHARMACEUTICALS INC SUB AKORN INCNDA012015_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA090233_001RXBENZTROPINE MESYLATE (1MG/ML)INJECTIONFalseAP2009-07-28BENZTROPINE MESYLATE
2ANDA090287_001RXBENZTROPINE MESYLATE (1MG/ML)INJECTIONFalseAP2009-08-31BENZTROPINE MESYLATE
3ANDA091152_001RXBENZTROPINE MESYLATE (1MG/ML)INJECTIONFalseAP2010-03-29BENZTROPINE MESYLATE
4ANDA091525_001RXBENZTROPINE MESYLATE (1MG/ML)INJECTIONFalseAP2013-02-05BENZTROPINE MESYLATE
5NDA012015_001RXBENZTROPINE MESYLATE (1MG/ML)INJECTIONTrueAPCOGENTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
157107a07-3347-4eac-8d3e-7d5e0c0a2974 (view SPL)Benztropine Mesylate Injection, USPprescriptionHuman PrescriptionAkorn2013-05-314174780012
2633411f3-f092-4f59-84b0-6ac12a8aa013 (view SPL)Benztropine Mesylate Injection, USPprescriptionHuman PrescriptionAmerican Regent, Inc.2011-05-101005170785
395620f40-5ddf-41b8-80a5-f658248f26f0 (view SPL)BENZTROPINE MESYLATE INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2014-03-116001439729
4b03bd28e-3b44-41e4-9a7e-28b9d7975245 (view SPL)BenztropineprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-07-012633230970
5b707bc17-3ab4-47a9-a83e-ebd1d384a9d8 (view SPL)Cogentin (benztropine mesylate injection)prescriptionHuman PrescriptionOak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.)2013-05-104764780611
6bbacbb05-2e18-4cf9-b239-6addb60b7533 (view SPL)Benztropine Mesylate Injection, USP Rx OnlyprescriptionHuman PrescriptionNexus Pharmaceuticals IncMANUFACTURE2009-07-311147890300
7d61eae0d-a29d-45ef-bd41-07123e0c21f9 (view SPL)Benztropine Mesylate Injection, USPprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2013-05-312647250012
8ecaeaadf-0847-4605-a205-a674f75f8bb2 (view SPL)Benztropine Mesylate Injection, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture, Pack2015-05-082683820860

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