Dexchlorpheniramine Maleate

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 6 USDMF, 1 CEP/COS, 3 EU WC, 3 KDMF, 3 NDC API, 7 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

22 FDF Dossiers, 14 FDA Orange Book, 2 Europe, 3 South Africa, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML, SYRUP;ORAL - 2MG/5ML

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 3 SPI Pharma, 4 DKSH, 2 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 7 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 6 Actylis, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 1 Bioplus Life Sciences, 4 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 19 Kerry, 10 Microlex e.U, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 18 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

49 Fillers, Diluents & Binders, 26 Direct Compression, 20 Thickeners and Stabilizers, 16 Disintegrants & Superdisintegrants, 15 Co-Processed Excipients, 14 Film Formers & Plasticizers, 13 Granulation, 12 Lubricants & Glidants, 12 Taste Masking, 10 Coating Systems & Additives, 8 Parenteral, 7 Controlled & Modified Release, 7 Chewable & Orodispersible Aids, 6 Topical, 6 Solubilizers, 4 Emulsifying Agents, 3 Rheology Modifiers, 3 API Stability Enhancers, 1 Soft Gelatin

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4 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 Finished Drug Prices

2 Finished Drug Prices

MARKET PLACE

7 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents

2 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

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USFDA APPLICATION NUMBER - 88251 / DOSAGE - SYRUP;ORAL - 2MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dexchlorpheniramine Maleate(UNII: B10YD955QW) (Dexchlorpheniramine - UNII:3Q9Q0B929N)	Dexchlorpheniramine Maleate	2mg in 5

Inactive Ingredients

Ingredient Name	Morton Grove Pharmaceuticals, Inc.	Foxland Pharmaceuticals, Inc.
ALCOHOL(3K9958V90M)
ANHYDROUS CITRIC ACID(XF417D3PSL)
CAPTAN(EOL5G26Q9F)
Citric Acid Monohydrate(2968PHW8QP)
FD&C RED NO. 40(WZB9127XOA)
GLYCERIN(PDC6A3C0OX)
menthol, unspecified form(L7T10EIP3A)
METHYL ALCOHOL(Y4S76JWI15)
METHYLPARABEN(A2I8C7HI9T)
propylene glycol(6DC9Q167V3)
propylparaben(Z8IX2SC1OH)
sucrose(C151H8M554)
trisodium citrate dihydrate(B22547B95K)
Water(059QF0KO0R)

Drug Product Composition: Dexchlorpheniramine Maleate