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TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, TABLET;ORAL - 37.5MG;20MG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

Filters

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USFDA APPLICATION NUMBER - 12093 / DOSAGE - TABLET;ORAL - 40MG

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	BTA Pharmaceuticals, Inc.
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(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
POWDERED CELLULOSE(SMD1X3XO9M)

Drug Product Composition: Isosorbide Dinitrate