Isosorbide Dinitrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 15 USDMF, 3 CEP/COS, 5 JDMF, 7 KDMF, 3 NDC API, 7 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

115 FDF Dossiers, 65 FDA Orange Book, 21 Europe, 4 Canada, 2 Australia, 13 South Africa, 10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, TABLET;ORAL - 37.5MG;20MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 7 DKSH, 1 Jai Radhe Sales, 3 Faran Shimi Pharmaceutical, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 13 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

67 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 31 Direct Compression, 27 Thickeners and Stabilizers, 27 Controlled & Modified Release, 19 Granulation, 19 Disintegrants & Superdisintegrants, 17 Lubricants & Glidants, 16 Co-Processed Excipients, 15 Solubilizers, 13 Film Formers & Plasticizers, 11 Topical, 10 Taste Masking, 9 Parenteral, 9 Empty Capsules, 7 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 4 Coloring Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

9 NEWS #PharmaBuzz

9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 32 Finished Drug Prices

MARKET PLACE

10 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP

$ Xls

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USFDA APPLICATION NUMBER - 12093 / DOSAGE - TABLET;ORAL - 5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOSORBIDE DINITRATE(UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)	ISOSORBIDE DINITRATE	5mg \| 40mg

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	Golden State Medical Supply, Inc.	Hikma Pharmaceutical	REMEDYREPACK INC.	Avera McKennan Hospital	BluePoint Laboratories	BTA Pharmaceuticals, Inc.	American Health Packaging
AMMONIUM PHOSPHATE, DIBASIC(10LGE70FSU)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POWDERED CELLULOSE(SMD1X3XO9M)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)

Drug Product Composition: Isosorbide Dinitrate