Application 020884

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020884-001AGGRENOXASPIRIN; DIPYRIDAMOLE25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1999-11-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020884-001AGGRENOX25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1999-11-22a50c72e98297…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

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