FDA.reportPublic FDA data

Application 040829

Type
ANDA
Sponsor
AVANTHI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORPHENIRAMINE MALEATECHLORPHENIRAMINE MALEATETABLET, EXTENDED RELEASE;ORAL12MGNoYes

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
A040829-001CHLORPHENIRAMINE MALEATECHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13

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 UTC2022-10A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040829-001CHLORPHENIRAMINE MALEATE12MGTABLET, EXTENDED RELEASE / ORALRS2009-05-13a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorphen-12CHLORPHENIRAMINE MALEATEKVK-Tech, Inc.84409269-fe9b-469e-9a66-27b1475231a32018-12-19WarningsExact identifier
application applno (ANDA): 040829
application number: ANDA040829
ndc (product): 10702-017
Allergy ReliefCHLORPHENIRAMINE MALEATECVS Pharmacy626aa162-f5e3-45c0-b5ac-d70bff255aed2017-01-19WarningsExact identifier
application applno (ANDA): 040829
application number: ANDA040829
ndc (product): 69842-017

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-017Chlorphen-12Chlorpheniramine MaleateKVK-Tech, Inc.ANDACurrent
37205-117Chlorpheniramine MaleateChlorpheniramine MaleateCardinal Health, Inc.ANDACurrent
58809-363Chlorphen SRChlorpheniramine MaleateGM Pharmaceuticals, INCANDACurrent
69842-017Allergy ReliefChlorpheniramine MaleateCVS PharmacyANDACurrent