DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

55 API Suppliers, 14 USDMF, 13 CEP/COS, 3 JDMF, 18 EU WC, 4 KDMF, 9 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

338 FDF Dossiers, 24 FDA Orange Book, 197 Europe, 6 Canada, 52 South Africa, 59 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG, SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 Evonik, 3 Rochem International Inc, 23 SPI Pharma, 6 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 6 Kirsch Pharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 28 BASF, 1 CD Formulation, 12 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 39 Direct Compression, 35 Granulation, 34 Disintegrants & Superdisintegrants, 32 Taste Masking, 32 Thickeners and Stabilizers, 29 Controlled & Modified Release, 25 Lubricants & Glidants, 24 Solubilizers, 23 Film Formers & Plasticizers, 22 Chewable & Orodispersible Aids, 21 Parenteral, 17 Topical, 13 Co-Processed Excipients, 9 Emulsifying Agents, 7 API Stability Enhancers, 7 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 6 News #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 63 Regulatory FDF Prices, 7 Annual Reports

MARKET PLACE

28 APIs, 10 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

7 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 5 USP, 24 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

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USFDA APPLICATION NUMBER - 21165 / DOSAGE - TABLET;ORAL - 5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Desloratadine(UNII: FVF865388R) (Desloratadine - UNII:FVF865388R)	Desloratadine	0.5mg in 1 \| 5mg

Inactive Ingredients

Ingredient Name	Merck Sharp & Dohme Corp.	Paddock Laboratories, LLC	AvKARE, Inc.	AvPAK	Bryant Ranch Prepack	Sandoz Inc	A-S Medication Solutions	Virtus Pharmaceuticals	Mylan Pharmaceuticals Inc.
Aluminum Oxide(LMI26O6933)
anhydrous citric acid(XF417D3PSL)
carnauba wax(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
edetate disodium(7FLD91C86K)
FD&C Blue No. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C Yellow No. 6(H77VEI93A8)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
lactose monohydrate(EWQ57Q8I5X)
MAGNESIUM HYDROXIDE(NBZ3QY004S)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
propylene glycol(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium benzoate(OJ245FE5EU)
SODIUM LAURYL SULFATE(368GB5141J)
sorbitol(506T60A25R)
STARCH, CORN(O8232NY3SJ)
sucrose(C151H8M554)
Talc(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
trisodium citrate dihydrate(B22547B95K)
water(059QF0KO0R)
white wax(7G1J5DA97F)
ZINC STEARATE(H92E6QA4FV)

Setid 5b79aff4 9bed 429d 8def A7929293387d Applno 21165 Form Tablet Oral Dosage 5mg - Drug Product Composition: DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR