Home Applications 204552 Application 204552
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE;ORAL 25MG;200MG No No
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 A204552-001 ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE / ORAL 2019-03-20
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 A204552-001 ASPIRIN AND DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE / ORAL 2019-03-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204552-001 ASPIRIN AND DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE / ORAL 2019-03-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204552-001 ASPIRIN AND DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE / ORAL 2019-03-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204552-001 ASPIRIN AND DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE / ORAL 2019-03-20 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51407-271 Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole Golden State Medical Supply, Inc. ANDA Current 51407-271 Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole Golden State Medical Supply ANDA Current 51407-271 Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole Golden State Medical Supply, Inc. ANDA Current 62175-330 Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole Lannett Company, Inc. ANDA Current 62175-330 Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole Lannett Company, Inc. ANDA Current 62175-330 Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole Lannett Company, Inc. ANDA Current 62175-330 Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole Lannett Company, Inc. ANDA Current