Levocetirizine Dihydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 14 USDMF, 2 CEP/COS, 4 JDMF, 16 EU WC, 23 KDMF, 17 NDC API, 40 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

222 FDF Dossiers, 29 FDA Orange Book, 60 Europe, 39 South Africa, 94 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 2.5MG/5ML, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 1 SPI Pharma, 2 Seqens, 5 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 10 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 35 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 24 Thickeners and Stabilizers, 24 Controlled & Modified Release, 23 Direct Compression, 15 Disintegrants & Superdisintegrants, 15 Solubilizers, 14 Film Formers & Plasticizers, 14 Granulation, 13 Co-Processed Excipients, 13 Taste Masking, 12 Topical, 12 Parenteral, 11 Lubricants & Glidants, 7 Emulsifying Agents, 5 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 24 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 59 Finished Drug Prices, 7 Annual Reports

MARKET PLACE

43 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents

1 US Patents

REF. STANDARDS & IMPURITIES

2 USP, 9 Others

ANALYTICAL

4 BioAnalytical Methods

4 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 209090 / DOSAGE - SOLUTION;ORAL - 2.5MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOCETIRIZINE DIHYDROCHLORIDE(UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5mg in 5 \| 2.5mg in 5 \| 2.5mg in 5

Inactive Ingredients

Ingredient Name	Apotex Corp.	Chattem, Inc.	Lannett Company, Inc.
ACETIC ACID(Q40Q9N063P)
GLYCERIN(PDC6A3C0OX)
MALTITOL(D65DG142WK)
METHYLPARABEN(A2I8C7HI9T)
PROPYLPARABEN(Z8IX2SC1OH)
SACCHARIN SODIUM(SB8ZUX40TY)
SODIUM ACETATE(4550K0SC9B)
SUCRALOSE(96K6UQ3ZD4)
WATER(059QF0KO0R)

Drug Product Composition: Levocetirizine Dihydrochloride