Isosorbide Dinitrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 15 USDMF, 3 CEP/COS, 5 JDMF, 7 KDMF, 3 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

120 FDF Dossiers, 65 FDA Orange Book, 26 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TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, TABLET;ORAL - 37.5MG;20MG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, 9 DKSH, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 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 Esteem Industries, 1 Finar, 9 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 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, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 29 Thickeners and Stabilizers, 27 Direct Compression, 24 Granulation, 21 Controlled & Modified Release, 17 Disintegrants & Superdisintegrants, 16 Lubricants & Glidants, 15 Solubilizers, 12 Topical, 12 Film Formers & Plasticizers, 11 Co-Processed Excipients, 10 Taste Masking, 9 Empty Capsules, 8 Emulsifying Agents, 8 Chewable & Orodispersible Aids, 8 Parenteral, 5 API Stability Enhancers, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

9 News #PharmaBuzz

9 News #PharmaBuzz

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 25 Regulatory FDF Prices

MARKET PLACE

11 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM

2 EDQM

$ Xls

Filters

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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	Golden State Medical Supply, Inc.	Hikma Pharmaceutical	Major Pharmaceuticals	McKesson Contract Packaging	NCS HealthCare of KY, Inc dba Vangard Labs	Avera McKennan Hospital	REMEDYREPACK INC.	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 CORN(AG9B65PV6B)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)

Setid Abb3ad49 73a8 49c5 Adc5 164d052971d7 Applno 12093 Form Tablet Oral Dosage 5mg - Drug Product Composition: Isosorbide Dinitrate