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Setid A4fd82b1 30e9 4480 A361 A84af05b7e77 Applno 16455 Form Tape Topical Dosage 0 004mg Sq Cm - Drug Product Composition: Flurandrenolone

Flurandrenolone

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

5 API Suppliers, 5 USDMF, 1 NDC API, 1 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

14 FDF Dossiers, 13 FDA Orange Book, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TAPE;TOPICAL - 0.004MG/SQ CM

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 DKSH, 2 Nanjing Well Pharmaceutical, 3 Kirsch Pharma, 3 Actylis, 5 BASF, 2 CD Formulation, 2 Finar, 1 Gangwal Chemicals, 3 Microlex e.U, 1 Pluviaendo, 4 Roquette, 1 Symrise, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

13 Topical, 8 Parenteral, 8 Film Formers & Plasticizers, 7 Thickeners and Stabilizers, 6 Coating Systems & Additives, 6 Solubilizers, 3 Lubricants & Glidants, 3 Fillers, Diluents & Binders, 3 Emulsifying Agents, 1 Granulation, 1 Direct Compression, 1 Surfactant & Foaming Agents, 1 Taste Masking, 1 Controlled & Modified Release

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 6 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

2 US Medicaid Prescriptions

REF. STANDARDS & IMPURITIES

1 Others

1 Others

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USFDA APPLICATION NUMBER - 16455 / DOSAGE - TAPE;TOPICAL - 0.004MG/SQ CM

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FLURANDRENOLIDE(UNII: 8EUL29XUQT) (FLURANDRENOLIDE - UNII:8EUL29XUQT)	FLURANDRENOLIDE	4ug in 1

Setid A4fd82b1 30e9 4480 A361 A84af05b7e77 Applno 16455 Form Tape Topical Dosage 0 004mg Sq Cm - Drug Product Composition: Flurandrenolone

Flurandrenolone

Flurandrenolone

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

5 API Suppliers

5 USDMF

1 NDC API

1 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

14 FDF Dossiers

13 FDA Orange Book

1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TAPE;TOPICAL - 0.004MG/SQ CM

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 DKSH

2 Nanjing Well Pharmaceutical

3 Kirsch Pharma

3 Actylis

5 BASF

2 CD Formulation

2 Finar

1 Gangwal Chemicals

3 Microlex e.U

1 Pluviaendo

4 Roquette

1 Symrise

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

13 Topical

8 Parenteral

8 Film Formers & Plasticizers

7 Thickeners and Stabilizers

6 Coating Systems & Additives

6 Solubilizers

3 Lubricants & Glidants

3 Fillers, Diluents & Binders

3 Emulsifying Agents

1 Granulation

1 Direct Compression

1 Surfactant & Foaming Agents

1 Taste Masking

1 Controlled & Modified Release

DIGITAL CONTENT

1 Data Compilation #PharmaFlow

6 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

REF. STANDARDS & IMPURITIES

1 Others

Filters

LOTION;TOPICAL - 0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons