Application 087520

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORPHENIRAMINE MALEATECHLORPHENIRAMINE MALEATESYRUP;ORAL2MG/5MLNoNo

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
A087520-001CHLORPHENIRAMINE MALEATECHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-1084e616aacf4f…
2026-08-18 06:07:402026-07A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-103f01610625f2…
2019-09-15 20:21 UTC2019-09A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087520-001CHLORPHENIRAMINE MALEATE2MG/5MLSYRUP / ORAL1982-02-10f41ea6bd6efb…

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCHLORPHENIRAMINE MALEATECVS PHARMACYa645b31e-7da7-4fe6-a04f-ac794ef524942025-09-03WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Allergy ReliefCHLORPHENIRAMINE MALEATEChain Drug Consortium34005c55-3176-4f28-9a3b-7dc6fefd01fe2025-07-19WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
AllergyCHLORPHENIRAMINE MALEATEBryant Ranch Prepackc948e612-a491-4ad0-adb9-cf31ef76e4d82025-05-12WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
ALLERGYCHLORPHENIRAMINE MALEATEA-S Medication Solutionsb199b5ee-fff3-4746-be68-a04060586f8e2024-07-18WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Chlorpheniramine Maleate 4 mgCHLORPHENIRAMINE MALEATEBryant Ranch Prepack54681242-c861-4415-b5c0-d3ab55b62be12024-05-17WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEGeri-Care Pharmaceutical Corp92d90b41-0627-121e-e053-2995a90a2df12023-10-26WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Allergy ReliefCHLORPHENIRAMINE MALEATEGood Sensef88e2654-8e97-4cf6-9c36-01aeb51a91022021-11-30WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
AllergyCHLORPHENIRAMINE MALEATEAllegiant Health4305ad50-d2a5-4d3e-9d92-cbf26e856a162018-12-26WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Chlorphen-12CHLORPHENIRAMINE MALEATEKVK-Tech, Inc.84409269-fe9b-469e-9a66-27b1475231a32018-12-19WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Allergy TimeCHLORPHENIRAMINE MALEATETime Cap Labs Inc588c424a-8dd6-417e-8f76-2ce0cc2b0c122018-12-17WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Anti AllergyCHLORPHENIRAMINE MALEATERichmond Pharmaceuticals, Inc.316db99f-5a13-48e0-9a6b-ab7a76fe4d282017-10-30WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Anti AllergyCHLORPHENIRAMINE MALEATEAdvance Pharmaceutical Inc.6fb948b3-cf48-4503-921e-e8279f2e95f82017-10-30WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
Allergy ReliefCHLORPHENIRAMINE MALEATECVS Pharmacy626aa162-f5e3-45c0-b5ac-d70bff255aed2017-01-19WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsName fallback
generic name: CHLORPHENIRAMINE MALEATE

Reported adverse events (FAERS/openFDA)#

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