Estradiol

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

74 API Suppliers, 11 USDMF, 12 CEP/COS, 2 JDMF, 11 EU WC, 10 KDMF, 37 NDC API, 3 VMF, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

82 Drugs in Development

82 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

699 FDF Dossiers, 229 FDA Orange Book, 379 Europe, 29 Canada, 28 Australia, 27 South Africa, 7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR, INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR, SYSTEM;TRANSDERMAL - 0.025MG/24HR, SYSTEM;TRANSDERMAL - 0.0375MG/24HR, SYSTEM;TRANSDERMAL - 0.05MG/24HR, SYSTEM;TRANSDERMAL - 0.075MG/24HR, SYSTEM;TRANSDERMAL - 0.1MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR, TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;VAGINAL - 10MCG, TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 0.5MG;100MG, CAPSULE;ORAL - 1MG;100MG, GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION), FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR, TABLET;ORAL - 0.25MG;0.5MG, TABLET;ORAL - 0.5MG;1MG, GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION), SPRAY;TRANSDERMAL - 1.53MG/SPRAY, GEL;TRANSDERMAL - 0.1% (0.25GM/PACKET), GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET), GEL;TRANSDERMAL - 0.1% (0.75GM/PACKET), GEL;TRANSDERMAL - 0.1% (1.25GM/PACKET), GEL;TRANSDERMAL - 0.1% (1GM/PACKET), CREAM;VAGINAL - 0.01%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 8 SPI Pharma, 12 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 9 Kirsch Pharma, 4 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 33 BASF, 1 BioSpectra, 2 CD Formulation, 1 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 20 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 40 Direct Compression, 38 Thickeners and Stabilizers, 36 Granulation, 35 Solubilizers, 34 Topical, 31 Disintegrants & Superdisintegrants, 30 Controlled & Modified Release, 27 Parenteral, 22 Film Formers & Plasticizers, 21 Lubricants & Glidants, 18 Taste Masking, 17 Emulsifying Agents, 14 Co-Processed Excipients, 10 Chewable & Orodispersible Aids, 9 Empty Capsules, 9 API Stability Enhancers, 8 Surfactant & Foaming Agents, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 44 News #PharmaBuzz

GLOBAL SALES INFORMATION

42 US Medicaid Prescriptions, 84 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

14 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

129 US Patents, 4 US Exclusivities, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 2 USP, 16 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20907 / DOSAGE - TABLET;ORAL - 1MG;0.5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	1mg \| 0.5mg
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)	NORETHINDRONE ACETATE	0.5mg \| 0.1mg

Inactive Ingredients

Ingredient Name	Amneal Pharmaceuticals LLC	Amneal Pharmaceuticals NY LLC	Lupin Pharmaceuticals, Inc.	Mylan Pharmaceuticals Inc.	Naari Pte. Limited	Gemini Laboratories, LLC	Novo Nordisk
COPOVIDONE K25-31(D9C330MD8B)
COPOVIDONE(D9C330MD8B)
FD&C YELLOW NO. 6(H77VEI93A8)
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POLYSORBATE 80(6OZP39ZG8H)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TRIACETIN(XHX3C3X673)

Setid 0f943869 41a2 4f7e 943d Dd8c17996dd8 Applno 20907 Form Tablet Oral Dosage 1mg 0 5mg - Drug Product Composition: Estradiol

Estradiol

Estradiol

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

74 API Suppliers

11 USDMF

12 CEP/COS

2 JDMF

11 EU WC

10 KDMF

37 NDC API

3 VMF

21 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

82 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

699 FDF Dossiers

229 FDA Orange Book

379 Europe

29 Canada

28 Australia

27 South Africa

7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR

INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR

SYSTEM;TRANSDERMAL - 0.025MG/24HR

SYSTEM;TRANSDERMAL - 0.0375MG/24HR

SYSTEM;TRANSDERMAL - 0.05MG/24HR

SYSTEM;TRANSDERMAL - 0.075MG/24HR

SYSTEM;TRANSDERMAL - 0.1MG/24HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR

TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 1MG;0.5MG

TABLET;VAGINAL - 10MCG

TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 0.5MG;100MG

CAPSULE;ORAL - 1MG;100MG

GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION)

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR

TABLET;ORAL - 0.25MG;0.5MG

TABLET;ORAL - 0.5MG;1MG

GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION)

SPRAY;TRANSDERMAL - 1.53MG/SPRAY

GEL;TRANSDERMAL - 0.1% (0.25GM/PACKET)

GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET)

GEL;TRANSDERMAL - 0.1% (0.75GM/PACKET)

GEL;TRANSDERMAL - 0.1% (1.25GM/PACKET)

GEL;TRANSDERMAL - 0.1% (1GM/PACKET)

CREAM;VAGINAL - 0.01%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

8 SPI Pharma

12 DKSH

6 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

8 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

9 Kirsch Pharma

4 ACG Worldwide

8 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

TABLET;ORAL - 0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;VAGINAL - 25MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons