Aspirin / Dipyridamole Oral Capsule

Brand(s)
Aggrenox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-11-17)
Oldest Current Product
1999-12-19
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
ORAL CAPSULE\ASPIRIN:DIPYRIDAMOLE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\ASPIRIN: DIPYRIDAMOLE
SPL Active
ORAL\CAPSULE\ASPIRIN: DIPYRIDAMOLE
SPL Moiety
ORAL\CAPSULE\ASPIRIN: DIPYRIDAMOLE

product(s) by strength(s)

aspirin 25 mg / dipyridamole 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970001AggrenoxNDABoehringer Ingelheim Pharmaceuticals, Inc.1999-12-19ASPIRIN, DIPYRIDAMOLEORALCAPSULENDA020884938ab0b5-8377-404a-8f61-5c630bda5932

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540575NDA AUTHORIZED GENERICRoxane Laboratories, Inc2015-06-24ASPIRIN, DIPYRIDAMOLEORALCAPSULENDA0208841f059a7a-8fd4-48a9-a36d-daa6dcc93c81
2000933040NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc2015-07-01ASPIRIN, DIPYRIDAMOLEORALCAPSULENDA020884dab3b5cd-9026-4994-bb12-e5de6117d532

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950656AggrenoxNDARebel Distributors Corp1999-12-19ASPIRIN, DIPYRIDAMOLEORALCAPSULE005970001NDA0208846473563d-b4df-4434-a74e-f8fa3cb9994f
2548685143AggrenoxNDAPhysicians Total Care, Inc.2004-08-24ASPIRIN, DIPYRIDAMOLEORALCAPSULE005970001NDA020884e729d829-4bd0-4074-85ea-e0f9f5d7cdb5
3681513971AggrenoxNDACarilion Materials Management1999-12-19ASPIRIN, DIPYRIDAMOLEORALCAPSULE005970001NDA020884f07c8535-f9fb-4697-9b63-1ab22210efc9

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA078804ASPIRIN AND DIPYRIDAMOLEBARR LABORATORIES INC2009-08-14ANDA078804_001
2NDA020884AGGRENOXBOEHRINGER INGELHEIM PHARMACEUTICALS INC1999-11-22p6015577, TO REDUCE THE RISK OF STROKE IN PATIENTS WHO HAVE HAD TRANSIENT ISCHEMIA OF THE BRAIN OR COMPLETED ISCHEMIC STROKE DUE TO THROMBOSISNDA020884_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078804_001RXDIPYRIDAMOLE (200MG), ASPIRIN (25MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2009-08-14ASPIRIN AND DIPYRIDAMOLE
2NDA020884_001RXDIPYRIDAMOLE (200MG), ASPIRIN (25MG)ORALCAPSULE, EXTENDED RELEASETrueAB1999-11-22AGGRENOX

patent(s)

#idexpiration dateapplication(s)
1p6015577 (view patent)2017-01-18NDA020884

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11f059a7a-8fd4-48a9-a36d-daa6dcc93c81 (view SPL)These highlights do not include all the information needed to use ASPIRIN and extended release DIPYRIDAMOLE capsules safely and effectively. See full prescribing information for ASPIRIN and extended release DIPYRIDAMOLE capsules. ASPIRIN and extended release DIPYRIDAMOLE capsulesInitial U.S. Approval: 1999prescriptionHuman PrescriptionRoxane Laboratories, IncANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-241000540575
26473563d-b4df-4434-a74e-f8fa3cb9994f (view SPL)These highlights do not include all the information needed to use Aggrenox Capsules safely and effectively. See full prescribing information for Aggrenox Capsules. AGGRENOX (aspirin/extended-release dipyridamole) Capsules Initial U.S. Approval: 1999prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-011216950656
3938ab0b5-8377-404a-8f61-5c630bda5932 (view SPL)These highlights do not include all the information needed to use AGGRENOX safely and effectively. See full prescribing information for AGGRENOX. AGGRENOX (aspirin/extended-release dipyridamole) CapsulesInitial U.S. Approval: 1999prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-11-1713005970001
4dab3b5cd-9026-4994-bb12-e5de6117d532 (view SPL)These highlights do not include all the information needed to use Aspirin and Extended-Release Dipyridamole Capsules safely and effectively. See full prescribing information for Aspirin and Extended-Release Dipyridamole Capsules. Aspirin and Extended-Release Dipyridamole Capsules Aspirin and Extended-Release Dipyridamole Capsules .Initial U.S. Approval: 1999prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-011000933040
5e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 (view SPL)These highlights do not include all the information needed to use Aggrenox Capsules safely and effectively. See full prescribing information for Aggrenox Capsules. AGGRENOX (aspirin/extended-release dipyridamole) Capsules Initial U.S. Approval: 1999prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-04-162548685143
6f07c8535-f9fb-4697-9b63-1ab22210efc9 (view SPL)These highlights do not include all the information needed to use Aggrenox Capsules safely and effectively. See full prescribing information for Aggrenox Capsules. AGGRENOX (aspirin/extended-release dipyridamole) Capsules Initial U.S. Approval: 1999prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-12-052681513971

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