FDA.reportPublic FDA data

Application 020884

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AGGRENOXASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORAL25MG;200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3040Aspirin and DipyridamoleAspirin and DipyridamoleTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0597-0001Aggrenoxaspirin and dipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0001Aggrenoxaspirin and dipyridamoleBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0001Aggrenoxaspirin and dipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0001Aggrenoxaspirin and dipyridamoleBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
21695-656Aggrenoxaspirin and dipyridamoleRebel Distributors Corp.NDACurrent
68151-3971Aggrenoxaspirin and dipyridamoleCarilion Materials ManagementNDACurrent
70436-092aspirin and dipyridamoleaspirin and dipyridamoleSlate Run Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
70436-092aspirin and dipyridamoleaspirin and dipyridamoleSlate Run Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
70436-092aspirin and dipyridamoleaspirin and dipyridamoleSlate Run Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
70436-092aspirin and dipyridamoleaspirin and dipyridamoleSlate Run Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67496SUPPL2021-05-17
67490SUPPL2021-05-17
61256SUPPL2020-01-10
61250SUPPL2019-12-12
56450SUPPL2018-11-15
56419SUPPL2018-11-13
26124SUPPL2015-11-13
35573SUPPL2015-11-12
35572SUPPL2012-09-11
3653SUPPL2012-09-11
35571SUPPL2009-10-14
3652SUPPL2009-10-05
13668SUPPL2007-03-31
3650SUPPL2007-03-31
13669SUPPL2006-12-04
3651SUPPL2006-12-04
3649SUPPL2004-02-02
41781ORIG2003-04-30
35570ORIG2003-04-30
26123ORIG2003-04-30
13667SUPPL2003-04-24
3648SUPPL2001-04-23