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Setid 11c5d43d 7daf 4450 9341 2fdc4caa5f6e Applno 19568 Form Ointment Topical Dosage 0 1 - Drug Product Composition: Prednicarbate

Prednicarbate

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 2 USDMF, 3 CEP/COS, 2 KDMF, 4 NDC API, 7 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

23 FDF Dossiers, 4 FDA Orange Book, 15 Europe, 1 Canada, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 DKSH, 3 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 1 CD Formulation, 1 Finar, 5 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 1 Pluviaendo, 1 Prachin Chemical, 1 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Silverline Chemicals, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

14 Topical, 8 Lubricants & Glidants, 7 Thickeners and Stabilizers, 5 Fillers, Diluents & Binders, 4 Emulsifying Agents, 3 Parenteral, 3 Solubilizers, 2 Film Formers & Plasticizers, 1 Taste Masking, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 1 Regulatory FDF Prices

MARKET PLACE

1 APIs

1 APIs

REF. STANDARDS & IMPURITIES

2 EDQM, 6 Others

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USFDA APPLICATION NUMBER - 19568 / DOSAGE - OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
prednicarbate(UNII: V901LV1K7D) (prednicarbate - UNII:V901LV1K7D)	prednicarbate	1mg in 1

Inactive Ingredients

Ingredient Name	Valeant Pharmaceuticals North America LLC
citric acid monohydrate(2968PHW8QP)
GLYCERYL OLEATE(4PC054V79P)
octyldodecanol(461N1O614Y)
petrolatum(4T6H12BN9U)
propyl gallate(8D4SNN7V92)
propylene glycol(6DC9Q167V3)

Setid 11c5d43d 7daf 4450 9341 2fdc4caa5f6e Applno 19568 Form Ointment Topical Dosage 0 1 - Drug Product Composition: Prednicarbate

Prednicarbate

Prednicarbate

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

2 USDMF

3 CEP/COS

2 KDMF

4 NDC API

7 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

23 FDF Dossiers

4 FDA Orange Book

15 Europe

1 Canada

3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 DKSH

3 Nanjing Well Pharmaceutical

2 Kirsch Pharma

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

8 BASF

1 CD Formulation

1 Finar

5 Microlex e.U

1 Nitika Pharmaceutical Specialities

1 Pluviaendo

1 Prachin Chemical

1 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Silverline Chemicals

1 Valens Pharmachem

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

14 Topical

8 Lubricants & Glidants

7 Thickeners and Stabilizers

5 Fillers, Diluents & Binders

4 Emulsifying Agents

3 Parenteral

3 Solubilizers

2 Film Formers & Plasticizers

1 Taste Masking

1 API Stability Enhancers

1 Surfactant & Foaming Agents

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

1 Regulatory FDF Prices

MARKET PLACE

1 APIs

REF. STANDARDS & IMPURITIES

2 EDQM

6 Others

Filters

OINTMENT;TOPICAL - 0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CREAM;TOPICAL - 0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons