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Setid 9e48dba7 C706 44fc B04b 0fdcb2d72bc4 Applno 203340 Form Solution Oral Dosage 6mg Ml - Drug Product Composition: NCGC00024675-05

NCGC00024675-05

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

14 API Suppliers, 8 USDMF, 4 CEP/COS, 2 EU WC, 1 KDMF, 6 NDC API, 7 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

59 FDF Dossiers, 11 FDA Orange Book, 37 Europe, 1 Canada, 2 South Africa, 8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 6MG/ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Rochem International Inc, 14 SPI Pharma, 9 DKSH, 2 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 1 Clariant, 10 Corel Pharma Chem, 1 Esteem Industries, 2 Finar, 5 Gangwal Chemicals, 3 Ideal Cures, 1 Ingredion Pharma Solutions, 10 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 3 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 14 Roquette, 7 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives, 29 Fillers, Diluents & Binders, 17 Film Formers & Plasticizers, 15 Topical, 15 Controlled & Modified Release, 15 Taste Masking, 14 Thickeners and Stabilizers, 14 Chewable & Orodispersible Aids, 12 Parenteral, 11 Direct Compression, 9 Solubilizers, 9 Empty Capsules, 8 Disintegrants & Superdisintegrants, 6 Granulation, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 API Stability Enhancers, 3 Co-Processed Excipients, 2 Emulsifying Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 17 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 17 Regulatory FDF Prices

MARKET PLACE

10 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents

6 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 4 Others

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USFDA APPLICATION NUMBER - 203340 / DOSAGE - SOLUTION;ORAL - 6MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
nimodipine(UNII: 57WA9QZ5WH) (nimodipine - UNII:57WA9QZ5WH)	nimodipine	30mg in 10 \| 60mg in 20

Inactive Ingredients

Ingredient Name	Arbor Pharmaceuticals
alcohol(3K9958V90M)
glycerin(PDC6A3C0OX)
methylparaben(A2I8C7HI9T)
polyethylene glycol 400(B697894SGQ)
sodium phosphate, dibasic, unspecified form(GR686LBA74)
sodium phosphate, monobasic, unspecified form(3980JIH2SW)
water(059QF0KO0R)

Setid 9e48dba7 C706 44fc B04b 0fdcb2d72bc4 Applno 203340 Form Solution Oral Dosage 6mg Ml - Drug Product Composition: NCGC00024675-05

NCGC00024675-05

NCGC00024675-05

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

14 API Suppliers

8 USDMF

4 CEP/COS

2 EU WC

1 KDMF

6 NDC API

7 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

59 FDF Dossiers

11 FDA Orange Book

37 Europe

1 Canada

2 South Africa

8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;ORAL - 6MG/ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI

2 Rochem International Inc

14 SPI Pharma

9 DKSH

2 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

5 Actylis

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

11 BASF

1 Clariant

10 Corel Pharma Chem

1 Esteem Industries

2 Finar

5 Gangwal Chemicals

3 Ideal Cures

1 Ingredion Pharma Solutions

10 Kerry

3 Kima Chemical

6 Lonza Capsugel

3 Microlex e.U

2 Nomisma Healthcare

1 Novo Excipients

2 Pluviaendo

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

14 Roquette

7 Seppic

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives

29 Fillers, Diluents & Binders

17 Film Formers & Plasticizers

15 Topical

15 Controlled & Modified Release

15 Taste Masking

14 Thickeners and Stabilizers

14 Chewable & Orodispersible Aids

12 Parenteral

11 Direct Compression

9 Solubilizers

9 Empty Capsules

8 Disintegrants & Superdisintegrants

SOLUTION;ORAL - 3MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons