FDA.reportPublic FDA data

Application 040458

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBINOXAMINE MALEATECARBINOXAMINE MALEATESOLUTION;ORAL4MG/5MLNoYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040458-001CARBINOXAMINE MALEATECARBINOXAMINE MALEATE4MG/5MLSOLUTION / ORALRS2003-04-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A040458-001CARBINOXAMINE MALEATE4MG/5MLSOLUTION / ORALRS2003-04-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040458-001CARBINOXAMINE MALEATE4MG/5MLSOLUTION / ORALRS2003-04-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040458-001CARBINOXAMINE MALEATE4MG/5MLSOLUTION / ORALRS2003-04-25a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbinoxamine MaleateCARBINOXAMINE MALEATEGenus Lifesciences Inc.9d11b197-cfdc-4b9b-9935-2920ccb6e5222024-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040458
application number: ANDA040458

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, Inc.ANDACurrent
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
51991-334Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-334Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-334Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-334Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22147ORIG2006-04-20