Nisoldipine

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 8 USDMF, 2 JDMF, 1 EU WC, 2 NDC API, 4 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 16 FDA Orange Book, 1 Europe, 2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 17MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 34MG, TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8.5MG

RELATED EXCIPIENT COMPANIES

2 Evonik, 2 Seqens, 3 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 11 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 8 Ideal Cures Pvt Ltd, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 3 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Coating Systems & Additives, 37 Fillers, Diluents & Binders, 29 Controlled & Modified Release, 15 Granulation, 15 Direct Compression, 12 Lubricants & Glidants, 12 Solubilizers, 9 Film Formers & Plasticizers, 9 Co-Processed Excipients, 8 Thickeners and Stabilizers, 8 Topical, 5 Parenteral, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 2 Disintegrants & Superdisintegrants, 1 Chewable & Orodispersible Aids, 1 Surfactant & Foaming Agents, 1 Rheology Modifiers

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1 NEWS #PharmaBuzz

1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 1 Finished Drug Prices

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USFDA APPLICATION NUMBER - 20356 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 17MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NISOLDIPINE(UNII: 4I8HAB65SZ) (NISOLDIPINE - UNII:4I8HAB65SZ)	NISOLDIPINE	34mg \| 17mg \| 8.5mg

Inactive Ingredients

Ingredient Name	Shionogi Inc.
CARNAUBA WAX(R12CBM0EIZ)
FD&C YELLOW NO. 5(I753WB2F1M)
FERRIC OXIDE RED(1K09F3G675)
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Nisoldipine

Nisoldipine

Nisoldipine

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers

8 USDMF

2 JDMF

1 EU WC

2 NDC API

4 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers

16 FDA Orange Book

1 Europe

2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

TABLET, EXTENDED RELEASE;ORAL - 17MG

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

TABLET, EXTENDED RELEASE;ORAL - 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET, EXTENDED RELEASE;ORAL - 34MG

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

TABLET, EXTENDED RELEASE;ORAL - 8.5MG

RELATED EXCIPIENT COMPANIES

2 Evonik

2 Seqens

3 DKSH

4 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

23 BASF

11 Corel Pharma Chem

2 DFE Pharma

1 Finar

5 Gangwal Chemicals

8 Ideal Cures Pvt Ltd

28 Kerry

3 Kima Chemical

6 Lonza Capsugel

9 Microlex e.U

2 Nomisma Healthcare

2 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

1 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

3 Roquette

6 Seppic

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

3 Sigachi Industries

2 The Dow Chemical Company

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Coating Systems & Additives

37 Fillers, Diluents & Binders

29 Controlled & Modified Release

15 Granulation

15 Direct Compression

12 Lubricants & Glidants

12 Solubilizers

9 Film Formers & Plasticizers

9 Co-Processed Excipients

8 Thickeners and Stabilizers

8 Topical

5 Parenteral

5 Empty Capsules

4 Vegetarian Capsules

4 API Stability Enhancers

4 Taste Masking

TABLET, EXTENDED RELEASE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons