Didanosine

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ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 11 USDMF, 2 CEP/COS, 1 EU WC, 3 NDC API, 5 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

77 FDF Dossiers, 29 FDA Orange Book, 24 Europe, 18 South Africa, 6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SOLUTION;ORAL - 10MG/ML, CAPSULE, DELAYED REL PELLETS;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, DELAYED REL PELLETS;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

5 Evonik, 1 Rochem International Inc, 1 SPI Pharma, 12 DKSH, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 18 BASF, 13 Corel Pharma Chem, 4 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 8 Ideal Cures, 2 Ingredion Pharma Solutions, 10 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 6 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 12 Roquette, 7 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

59 Coating Systems & Additives, 31 Controlled & Modified Release, 29 Thickeners and Stabilizers, 24 Disintegrants & Superdisintegrants, 24 Fillers, Diluents & Binders, 14 Granulation, 14 Solubilizers, 13 Film Formers & Plasticizers, 12 Taste Masking, 12 Topical, 11 Direct Compression, 9 Empty Capsules, 9 Rheology Modifiers, 7 Co-Processed Excipients, 7 Lubricants & Glidants, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids, 2 Surfactant & Foaming Agents, 1 Parenteral

GLOBAL SALES INFORMATION

8 Regulatory FDF Prices

8 Regulatory FDF Prices

MARKET PLACE

1 FDF Dossiers

1 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 4 Others

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USFDA APPLICATION NUMBER - 21183 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
didanosine(UNII: K3GDH6OH08) (didanosine - UNII:K3GDH6OH08)	didanosine	400mg \| 250mg \| 200mg \| 125mg

Inactive Ingredients

Ingredient Name	Bristol-Myers Squibb Company
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
diethyl phthalate(UF064M00AF)
GELATIN, UNSPECIFIED(2G86QN327L)
methacrylic acid - methyl methacrylate copolymer (1:2)(5KY68S2577)
sodium hydroxide(55X04QC32I)
sodium starch glycolate type a potato(5856J3G2A2)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)

Setid 4bc249f2 7e8b 05cb 38ad 3085e947e0f1 Applno 21183 Form Capsule Delayed Rel Pellets Oral Dosage 125mg - Drug Product Composition: Didanosine

Didanosine

Didanosine

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ACTIVE PHARMA INGREDIENTS

16 API Suppliers

11 USDMF

2 CEP/COS

1 EU WC

3 NDC API

5 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

77 FDF Dossiers

29 FDA Orange Book

24 Europe

18 South Africa

6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SOLUTION;ORAL - 10MG/ML

CAPSULE, DELAYED REL PELLETS;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, DELAYED REL PELLETS;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

5 Evonik

1 Rochem International Inc

1 SPI Pharma

12 DKSH

4 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

4 ACG Worldwide

3 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

18 BASF

13 Corel Pharma Chem

4 DFE Pharma

3 Doshion Polyscience

1 Esteem Industries

2 Finar

7 Gangwal Chemicals

8 Ideal Cures

2 Ingredion Pharma Solutions

10 Kerry

4 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

6 Microlex e.U

1 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

2 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

12 Roquette

7 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

11 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

2 Valens Pharmachem

3 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

59 Coating Systems & Additives

31 Controlled & Modified Release

29 Thickeners and Stabilizers

24 Disintegrants & Superdisintegrants

24 Fillers, Diluents & Binders

14 Granulation

14 Solubilizers

13 Film Formers & Plasticizers

12 Taste Masking

CAPSULE, DELAYED REL PELLETS;ORAL - 125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, DELAYED REL PELLETS;ORAL - 400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons