Norethisterone Acetate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 1 EU WC, 5 NDC API, 13 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

78 Drugs in Development

78 Drugs in Development

FINISHED DOSAGE FORMULATIONS

228 FDF Dossiers, 119 FDA Orange Book, 95 Europe, 7 Canada, 7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, 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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 6 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 19 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 35 Direct Compression, 32 Granulation, 31 Disintegrants & Superdisintegrants, 25 Solubilizers, 23 Thickeners and Stabilizers, 23 Controlled & Modified Release, 20 Lubricants & Glidants, 16 Taste Masking, 15 Parenteral, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 10 Emulsifying Agents, 9 Topical, 8 API Stability Enhancers, 8 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 47 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 30 Regulatory FDF Prices, 7 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

10 US Patents, 4 US Exclusivities, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 Others

$ Xls

Filters

Xls

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)

Drug Product Composition: Norethisterone Acetate