Home Applications 020884 Application 020884
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AGGRENOX ASPIRIN; DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE;ORAL 25MG;200MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020884-001 AGGRENOX ASPIRIN; DIPYRIDAMOLE 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 1999-11-22
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.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N020884-001 AGGRENOX 25MG;200MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 1999-11-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020884-001 AGGRENOX 25MG;200MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 1999-11-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020884-001 AGGRENOX 25MG;200MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 1999-11-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020884-001 AGGRENOX 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 1999-11-22 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-3040 Aspirin and Dipyridamole Aspirin and Dipyridamole Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0597-0001 Aggrenox aspirin and dipyridamole Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0001 Aggrenox aspirin and dipyridamole Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 0597-0001 Aggrenox aspirin and dipyridamole Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0001 Aggrenox aspirin and dipyridamole Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 21695-656 Aggrenox aspirin and dipyridamole Rebel Distributors Corp. NDA Current 68151-3971 Aggrenox aspirin and dipyridamole Carilion Materials Management NDA Current 70436-092 aspirin and dipyridamole aspirin and dipyridamole Slate Run Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current 70436-092 aspirin and dipyridamole aspirin and dipyridamole Slate Run Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current 70436-092 aspirin and dipyridamole aspirin and dipyridamole Slate Run Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current 70436-092 aspirin and dipyridamole aspirin and dipyridamole Slate Run Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current