Dermolate

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ACTIVE PHARMA INGREDIENTS

84 API Suppliers, 28 USDMF, 14 CEP/COS, 6 JDMF, 11 EU WC, 10 KDMF, 39 NDC API, 1 VMF, 32 Listed Suppliers

DEVELOPMENTS

53 Drugs in Development

53 Drugs in Development

FINISHED DOSAGE FORMULATIONS

597 FDF Dossiers, 240 FDA Orange Book, 285 Europe, 14 Canada, 8 Australia, 28 South Africa, 22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%, CREAM;TOPICAL - 5%;1%, OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, LOTION;TOPICAL - 2%, TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 8 SPI Pharma, 1 Pharm-RX Chemical, 5 Gangwal Healthcare, 29 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 4 Pfanstiehl, 23 Kirsch Pharma, 9 Dr. Paul Lohmann GmbH & Co. KGaA, 22 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 42 BASF, 3 BioSpectra, 4 CD Formulation, 1 Clariant, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Esteem Industries, 6 Finar, 16 Gangwal Chemicals, 4 Gloria Interchem, 2 Hayashibara, 2 Ideal Cures, 4 Ingredion Pharma Solutions, 19 Kerry, 3 Keval Exports, 9 Lubrizol Life Science Health, 17 Microlex e.U, 3 Nanjing Bold Chemical, 2 Neelkanth MineChem, 2 Nippon Fine Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Pharmachem, 33 Roquette, 21 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 2 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

84 Topical, 64 Thickeners and Stabilizers, 61 Solubilizers, 55 Parenteral, 51 Fillers, Diluents & Binders, 38 Emulsifying Agents, 36 Direct Compression, 33 Granulation, 26 Controlled & Modified Release, 25 Coating Systems & Additives, 25 Disintegrants & Superdisintegrants, 24 Surfactant & Foaming Agents, 24 Lubricants & Glidants, 23 Film Formers & Plasticizers, 18 Taste Masking, 15 Co-Processed Excipients, 14 API Stability Enhancers, 12 Chewable & Orodispersible Aids, 7 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 55 News #PharmaBuzz

GLOBAL SALES INFORMATION

38 US Medicaid Prescriptions, 54 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

39 APIs, 17 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 JP, 27 Others

ANALYTICAL

2 BioAnalytical Methods, 4 Analytical Methods

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USFDA APPLICATION NUMBER - 80693 / DOSAGE - CREAM;TOPICAL - 1%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hydrocortisone(UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10mg in 1

Inactive Ingredients

Ingredient Name	Lake Erie Medical DBA Quality Care Products LLC	Crown Laboratories
benzyl alcohol(LKG8494WBH)
CETYL ALCOHOL(936JST6JCN)
CETYL PALMITATE(5ZA2S6B08X)
GLYCERIN(PDC6A3C0OX)
glyceryl monostearate(230OU9XXE4)
ISOPROPYL PALMITATE(8CRQ2TH63M)
LACTIC ACID(33X04XA5AT)
PARAFFIN(I9O0E3H2ZE)
POLYOXYL 40 STEARATE(13A4J4NH9I)
POTASSIUM SORBATE(1VPU26JZZ4)
PROPYLENE GLYCOL(6DC9Q167V3)
SODIUM LAURYL SULFATE(368GB5141J)
SORBIC ACID(X045WJ989B)
SORBITAN MONOSTEARATE(NVZ4I0H58X)
STEARYL ALCOHOL(2KR89I4H1Y)
water(059QF0KO0R)

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Setid Cc58ae80 1f86 477b A2c7 E4c6d4a4ff0f Applno 80693 Form Cream Topical Dosage 1 - Drug Product Composition: Dermolate

Dermolate

Dermolate

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

84 API Suppliers

28 USDMF

14 CEP/COS

6 JDMF

11 EU WC

10 KDMF

39 NDC API

1 VMF

32 Listed Suppliers

DEVELOPMENTS

53 Drugs in Development

FINISHED DOSAGE FORMULATIONS

597 FDF Dossiers

240 FDA Orange Book

285 Europe

14 Canada

8 Australia

28 South Africa

22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

CREAM;TOPICAL - 5%;1%

OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 1%

LOTION;TOPICAL - 2%

TABLET;ORAL - 10MG

TABLET;ORAL - 20MG

TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 Rochem International Inc

8 SPI Pharma

1 Pharm-RX Chemical

5 Gangwal Healthcare

29 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

4 Pfanstiehl

23 Kirsch Pharma

9 Dr. Paul Lohmann GmbH & Co. KGaA

22 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

42 BASF

3 BioSpectra

4 CD Formulation

1 Clariant

15 Corel Pharma Chem

7 DFE Pharma

3 Esteem Industries

6 Finar

16 Gangwal Chemicals

4 Gloria Interchem

2 Hayashibara

2 Ideal Cures

4 Ingredion Pharma Solutions

19 Kerry

3 Keval Exports

9 Lubrizol Life Science Health

17 Microlex e.U

3 Nanjing Bold Chemical

2 Neelkanth MineChem

2 Nippon Fine Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Pharmachem

33 Roquette

21 Seppic

2 Shandong Focus Biotechnology Co., Ltd

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons