Noretisterone [DCIT]

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 15 USDMF, 7 CEP/COS, 4 JDMF, 4 EU WC, 3 NDC API, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

196 FDF Dossiers, 116 FDA Orange Book, 33 Europe, 13 Canada, 3 Australia, 17 South Africa, 14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.05MG;1MG, TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.35MG, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 6 DKSH, 8 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 12 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 30 Direct Compression, 27 Granulation, 21 Controlled & Modified Release, 18 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 15 Lubricants & Glidants, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 10 Taste Masking, 10 Solubilizers, 8 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 3 Parenteral

DIGITAL CONTENT

22 News #PharmaBuzz

22 News #PharmaBuzz

GLOBAL SALES INFORMATION

22 US Medicaid Prescriptions, 27 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

9 APIs, 1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 5 Others

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USFDA APPLICATION NUMBER - 16954 / DOSAGE - TABLET;ORAL-28 - 0.35MG **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
NORETHINDRONE(UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)	NORETHINDRONE	0.35mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Janssen Pharmaceuticals, Inc.
D&C GREEN No. 5(8J6RDU8L9X)
D&C YELLOW No. 10(35SW5USQ3G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T)
POVIDONE, UNSPECIFIED(FZ989GH94E)

Setid B4bcfbe3 8050 4bb6 B3e0 068ddfb60c93 Applno 16954 Form Tablet Oral 28 Dosage 0 35mg - Drug Product Composition: Noretisterone [DCIT]