Home Applications 090575 Application 090575
Type ANDA
Sponsor AMNEAL PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 15MG/5ML;6.25MG/5ML 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 A090575-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2011-02-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090575-001 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 · 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 A090575-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2011-02-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090575-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2011-02-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090575-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2011-02-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A090575-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2011-02-08 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 · 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65162-680 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-680 Promethazine Hydrochloride and Dextomethorphan Hydrobromide Promethazine Hydrochloride and Dextomethorphan Hydrobromide Amneal Pharmaceuticals ANDA Current 65162-680 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current 65162-680 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide Amneal Pharmaceuticals LLC ANDA Current