Acitretin

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ACTIVE PHARMA INGREDIENTS

18 API Suppliers, 10 USDMF, 6 CEP/COS, 3 EU WC, 7 NDC API, 5 Listed Suppliers, $ API Reference Price

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

113 FDF Dossiers, 23 FDA Orange Book, 67 Europe, 6 Canada, 4 Australia, 4 South Africa, 9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 SPI Pharma, 7 DKSH, 3 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 4 ACG Worldwide, 1 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 18 BASF, 2 DFE Pharma, 1 Esteem Industries, 1 Finar, 6 Gangwal Chemicals, 1 Ideal Cures, 1 Kerry, 1 Keval Exports, 3 Lonza Capsugel, 3 Microlex e.U, 2 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 14 Roquette, 1 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 1 Silverline Chemicals, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

31 Fillers, Diluents & Binders, 21 Thickeners and Stabilizers, 16 Granulation, 15 Solubilizers, 15 Direct Compression, 11 Coating Systems & Additives, 8 Co-Processed Excipients, 8 Film Formers & Plasticizers, 8 Empty Capsules, 7 Taste Masking, 7 Topical, 7 Controlled & Modified Release, 6 Parenteral, 5 Disintegrants & Superdisintegrants, 4 Lubricants & Glidants, 4 Chewable & Orodispersible Aids, 3 Coloring Agents, 3 Emulsifying Agents, 2 Surfactant & Foaming Agents, 1 Rheology Modifiers

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5 US Medicaid Prescriptions, 15 Regulatory FDF Prices

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9 APIs, 3 FDF Dossiers

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USFDA APPLICATION NUMBER - 19821 / DOSAGE - CAPSULE;ORAL - 22.5MG **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
ACITRETIN(UNII: LCH760E9T7) (ACITRETIN - UNII:LCH760E9T7)	ACITRETIN	25mg \| 10mg

Inactive Ingredients

Ingredient Name	GlaxoSmithKline Manufacturing SpA	Prasco Laboratories	Stiefel Laboratories Inc
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN, UNSPECIFIED(2G86QN327L)
MALTODEXTRIN(7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
SODIUM ASCORBATE(S033EH8359)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid Cec7851f C7af 4e9e A5e4 A585c70510d2 Applno 19821 Form Capsule Oral Dosage 22 5mg - Drug Product Composition: Acitretin

Acitretin

Acitretin

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ACTIVE PHARMA INGREDIENTS

18 API Suppliers

10 USDMF

6 CEP/COS

3 EU WC

7 NDC API

5 Listed Suppliers

$ API Reference Price

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

113 FDF Dossiers

23 FDA Orange Book

67 Europe

6 Canada

4 Australia

4 South Africa

9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

CAPSULE;ORAL - 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 SPI Pharma

7 DKSH

3 Boai NKY Pharmaceuticals Ltd

2 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

2 Kirsch Pharma

4 ACG Worldwide

1 Actylis

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

18 BASF

2 DFE Pharma

1 Esteem Industries

1 Finar

6 Gangwal Chemicals

1 Ideal Cures

1 Kerry

1 Keval Exports

3 Lonza Capsugel

3 Microlex e.U

2 Nanjing Bold Chemical

1 Nitika Pharmaceutical Specialities

1 Novo Excipients

2 Pharmatrans-Sanaq

2 Pluviaendo

1 Prachin Chemical

1 Qualicaps

14 Roquette

1 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

8 Sigachi Industries

1 Silverline Chemicals

1 Ulanqab Kema New Material

1 Valens Pharmachem

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

31 Fillers, Diluents & Binders

21 Thickeners and Stabilizers

16 Granulation

15 Solubilizers

15 Direct Compression

11 Coating Systems & Additives

8 Co-Processed Excipients

8 Film Formers & Plasticizers

8 Empty Capsules

7 Taste Masking

7 Topical

7 Controlled & Modified Release

6 Parenteral

CAPSULE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons