Home Applications 074951 Application 074951
Type ANDA
Sponsor STEVENS J Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG 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 A074951-001 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RS 1998-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074951-001 AB
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 A074951-001 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RS 1998-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074951-001 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RS 1998-08-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074951-001 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RS 1998-08-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A074951-001 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RS 1998-08-31 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 · 1 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-1312 Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate Lannett Company, Inc. ANDA Current 0527-1312 Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate Lannett Company, Inc. ANDA Current 69238-1993 Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate Amneal Pharmaceuticals LLC ANDA Current 69238-1993 Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate Amneal Pharmaceuticals NY LLC ANDA Current 69238-1993 Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate Amneal Pharmaceuticals NY LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76079 ORIG 2023-11-02 42905 ORIG 2003-08-04 8474 ORIG 1998-08-31