FDA.reportPublic FDA data

Application 040639

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBINOXAMINE MALEATECARBINOXAMINE MALEATETABLET; ORAL4MGYesNo
002CARBINOXAMINE MALEATECARBINOXAMINE MALEATETABLET;ORAL4MGNoNo

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
A040639-002CARBINOXAMINE MALEATECARBINOXAMINE MALEATE4MGTABLET / ORAL2008-05-30

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 UTC2022-10A040639-002CARBINOXAMINE MALEATE4MGTABLET / ORAL2008-05-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040639-002CARBINOXAMINE MALEATE4MGTABLET / ORAL2008-05-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040639-002CARBINOXAMINE MALEATE4MGTABLET / ORAL2008-05-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040639-002CARBINOXAMINE MALEATE4MGTABLET / ORAL2008-05-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040639-002AA174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A040639-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040639-002AA1ea99ee380514…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Karbinal ERCARBINOXAMINE MALEATEAytu Therapeutics, LLCc40b3f4e-2d71-41a1-a1fc-f64f387248792026-03-12Warnings, Adverse reactionsName fallback
generic name: CARBINOXAMINE MALEATE
Carbinoxamine Maleate Extended-Release Oral SuspensionCARBINOXAMINE MALEATENeos Therapeutics, LP199f46e5-6288-5627-e063-6294a90ae0862026-03-12Warnings, Adverse reactionsName fallback
generic name: CARBINOXAMINE MALEATE
Carbinoxamine MaleateCARBINOXAMINE MALEATEBluCrest Pharmaceuticals, LLC163db29b-f035-6696-e063-6294a90a7e062026-01-06Warnings, Adverse reactionsName fallback
brand name: Carbinoxamine Maleate
generic name: CARBINOXAMINE MALEATE
Carbinoxamine MaleateCARBINOXAMINE MALEATEBiocomp Pharma, Inc.14266e97-674b-b6a9-37a2-a955f0a01c4f2025-12-17Warnings, Adverse reactionsName fallback
brand name: Carbinoxamine Maleate
generic name: CARBINOXAMINE MALEATE
Carbinoxamine MaleateCARBINOXAMINE MALEATETRIPOINT THERAPEUTICS, LLC91ee2e99-082a-4157-b71b-1a7c0e5464fa2025-08-05Warnings, Adverse reactionsName fallback
brand name: Carbinoxamine Maleate
generic name: CARBINOXAMINE MALEATE
CARBINOXAMINE MALEATECARBINOXAMINE MALEATELeading Pharma, LLC02e13b55-2153-468e-a5bd-57dee062f47f2025-07-18Warnings, Adverse reactionsName fallback
brand name: CARBINOXAMINE MALEATE
generic name: CARBINOXAMINE MALEATE
Carbinoxamine MaleateCARBINOXAMINE MALEATEGenus Lifesciences Inc.9d11b197-cfdc-4b9b-9935-2920ccb6e5222024-03-06Warnings, Adverse reactionsName fallback
brand name: Carbinoxamine Maleate
generic name: CARBINOXAMINE MALEATE
RyVentCARBINOXAMINE MALEATECarwin Pharmaceutical Associates, LLC13ed76c7-49bd-4527-83dc-b4c7d0da9fff2024-01-09Warnings, Adverse reactionsName fallback
generic name: CARBINOXAMINE MALEATE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64376-605Carbinoxamine MaleateCarbinoxamine MaleatePar PharmaceuticalANDACurrent
64376-605Carbinoxamine MaleateCarbinoxamine MaleatePar PharmaceuticalANDACurrent
64376-605Carbinoxamine MaleateCarbinoxamine MaleatePar Pharmaceutical, Inc.ANDACurrent