FDA.reportPublic FDA data

Application 210663

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATESYRUP;ORAL1.5MG/5ML;5MG/5MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210663-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE1.5MG/5ML;5MG/5MLSYRUP / ORAL2019-06-11

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A210663-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2019-06-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210663-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2019-06-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210663-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2019-06-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210663-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2019-06-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A210663-001AA1ea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEKVK-Tech, Inc.26d7c90c-5e6b-4bdb-b06f-c76173a01c212026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTIONKVK-Tech, Inc.9a737416-08e0-4df6-897e-cf9d1b5f0b012026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGenus Lifesciences Inc.320ff639-9854-407b-9bbd-a035c4f173e12026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEPAI Holdings, LLC dba PAI Pharma71319a6f-aaf4-4bc5-8b40-a16c6f139be62026-02-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDENovel Laboratories, Inc.4050ae05-7f1a-48b7-99b9-f8db8aa027412024-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDELupin Pharmaceuticals,Inc.41ac90b3-f007-4eb2-9d41-ea626ced20172024-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDENovel Laboratories, Inc.b203c87c-1108-4eaa-8a57-87be776d8a702023-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Homatropine Methylbromide

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.