Chlorpheniramine Maleate

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ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 14 USDMF, 2 JDMF, 5 EU WC, 6 KDMF, 12 NDC API, 27 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

204 FDF Dossiers, 66 FDA Orange Book, 8 Europe, 34 Canada, 26 South Africa, 70 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 4MG/5ML;5MG/5ML, TABLET;ORAL - 2MG;200MG;30MG, TABLET;ORAL - 4MG;200MG;10MG, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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1 Minakem, 1 Evonik, 12 Rochem International Inc, 23 SPI Pharma, 2 Seqens, 27 DKSH, 2 Jai Radhe Sales, 3 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 17 Gangwal Healthcare, 2 Kewpie Corporation, 16 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 14 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 37 BASF, 1 Bioplus Life Sciences, 5 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 14 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 22 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 10 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 47 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 4 Ulanqab Kema New Material, 2 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus, 2 Zhejiang Huakang Pharmaceutical

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PATENTS & EXCLUSIVITIES

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4 US Patents

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 21441 / DOSAGE - TABLET;ORAL - 2MG;200MG;30MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2mg
IBUPROFEN(UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200mg
PSEUDOEPHEDRINE HYDROCHLORIDE(UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30mg

Inactive Ingredients

Ingredient Name	Haleon US Holdings LLC
CARNAUBA WAX(R12CBM0EIZ)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Chlorpheniramine Maleate