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SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

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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125 Fillers, Diluents & Binders, 73 Coating Systems & Additives, 64 Thickeners and Stabilizers, 55 Direct Compression, 52 Solubilizers, 45 Taste Masking, 44 Disintegrants & Superdisintegrants, 43 Controlled & Modified Release, 35 Topical, 33 Parenteral, 33 Granulation, 32 Film Formers & Plasticizers, 29 Lubricants & Glidants, 23 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 17 Rheology Modifiers, 16 Emulsifying Agents, 13 API Stability Enhancers, 9 Empty Capsules, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

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PATENTS & EXCLUSIVITIES

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4 US Patents

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 22113 / DOSAGE - TABLET;ORAL - 4MG;200MG;10MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4mg \| 4mg
IBUPROFEN(UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200mg \| 200mg
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10mg \| 10mg

Inactive Ingredients

Ingredient Name	Haleon US Holdings LLC
ACESULFAME POTASSIUM(23OV73Q5G9)
CARNAUBA WAX(R12CBM0EIZ)
CROSCARMELLOSE SODIUM(M28OL1HH48)
EGG PHOSPHOLIPIDS(1Z74184RGV)
FERRIC OXIDE RED(1K09F3G675)
GLYCERIN(PDC6A3C0OX)
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTIC ACID, UNSPECIFIED FORM(33X04XA5AT)
LECITHIN, SOYBEAN(1DI56QDM62)
MALTODEXTRIN(7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
PROPYL GALLATE(8D4SNN7V92)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
SUCRALOSE(96K6UQ3ZD4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Chlorpheniramine Maleate