Home Applications 040894 Application 040894
Type ANDA
Sponsor GENUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION;ORAL 325MG/15ML;7.5MG/15ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040894-001 AA
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 · 43 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 2022-09-29 23:25 UTC 2022-09 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17856-0640 Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate, Acetaminophen Atlantic Biologicals Corps ANDA Current 64376-640 Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate, Acetaminophen Par Pharmaceutical ANDA Current 64376-640 Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate, Acetaminophen Par Pharmaceutical ANDA Current 64950-343 Hydrocodone Bitartrate and Acetaminophen hydrocodone bitartrate and acetaminophen Genus Lifesciences Inc. ANDA Current 64950-343 Hydrocodone Bitartrate and Acetaminophen hydrocodone bitartrate and acetaminophen Genus Lifesciences Inc. ANDA Current 68094-714 Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen Precision Dose Inc. ANDA Current 68094-714 Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen Precision Dose Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76153 ORIG 2023-11-03