Novothyral

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 14 USDMF, 11 CEP/COS, 2 JDMF, 4 EU WC, 5 KDMF, 19 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

20 Drugs in Development

20 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

713 FDF Dossiers, 267 FDA Orange Book, 291 Europe, 41 Canada, 37 Australia, 33 South Africa, 44 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.0125MG;0.0031MG, TABLET;ORAL - 0.025MG;0.0063MG, TABLET;ORAL - 0.05MG;0.0125MG, TABLET;ORAL - 0.15MG;0.0375MG, TABLET;ORAL - 0.1MG;0.025MG, POWDER;INTRAVENOUS - 100MCG/VIAL, POWDER;INTRAVENOUS - 200MCG/VIAL, POWDER;INTRAVENOUS - 500MCG/VIAL, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, CAPSULE;ORAL - 0.013MG, CAPSULE;ORAL - 0.025MG, CAPSULE;ORAL - 0.0375MG, CAPSULE;ORAL - 0.044MG, CAPSULE;ORAL - 0.05MG, CAPSULE;ORAL - 0.0625MG, CAPSULE;ORAL - 0.075MG, CAPSULE;ORAL - 0.088MG, CAPSULE;ORAL - 0.112MG, CAPSULE;ORAL - 0.125MG, CAPSULE;ORAL - 0.137MG, CAPSULE;ORAL - 0.15MG, CAPSULE;ORAL - 0.175MG, CAPSULE;ORAL - 0.1MG, CAPSULE;ORAL - 0.2MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Rochem International Inc, 21 SPI Pharma, 9 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 8 Kirsch Pharma, 4 ACG Worldwide, 6 Actylis, 2 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 16 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 31 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

78 Fillers, Diluents & Binders, 39 Coating Systems & Additives, 34 Direct Compression, 31 Disintegrants & Superdisintegrants, 29 Thickeners and Stabilizers, 29 Granulation, 26 Parenteral, 24 Taste Masking, 20 Chewable & Orodispersible Aids, 19 Controlled & Modified Release, 19 Lubricants & Glidants, 15 Solubilizers, 12 Co-Processed Excipients, 9 Empty Capsules, 8 Film Formers & Plasticizers, 7 API Stability Enhancers, 7 Topical, 6 Emulsifying Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 94 News #PharmaBuzz

GLOBAL SALES INFORMATION

30 US Medicaid Prescriptions, 116 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

31 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

101 US Patents

101 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 202231 / DOSAGE - POWDER;INTRAVENOUS - 500MCG/VIAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOTHYROXINE SODIUM ANHYDROUS(UNII: 054I36CPMN) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE SODIUM ANHYDROUS	200ug in 5 \| 100ug in 5 \| 500ug in 5

Inactive Ingredients

Ingredient Name	Piramal Critical Care, Inc.
MANNITOL(3OWL53L36A)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(70WT22SF4B)

Setid 6e77ac5a 6404 2556 E053 2991aa0a92e6 Applno 202231 Form Powder Intravenous Dosage 500mcg Vial - Drug Product Composition: Novothyral

Novothyral

Novothyral

ACCESS ALL DATA

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

43 API Suppliers

14 USDMF

11 CEP/COS

2 JDMF

4 EU WC

5 KDMF

19 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

20 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

713 FDF Dossiers

267 FDA Orange Book

291 Europe

41 Canada

37 Australia

33 South Africa

44 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.0125MG;0.0031MG

TABLET;ORAL - 0.025MG;0.0063MG

TABLET;ORAL - 0.05MG;0.0125MG

TABLET;ORAL - 0.15MG;0.0375MG

TABLET;ORAL - 0.1MG;0.025MG

POWDER;INTRAVENOUS - 100MCG/VIAL

POWDER;INTRAVENOUS - 200MCG/VIAL

POWDER;INTRAVENOUS - 500MCG/VIAL

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

CAPSULE;ORAL - 0.013MG

CAPSULE;ORAL - 0.025MG

CAPSULE;ORAL - 0.0375MG

CAPSULE;ORAL - 0.044MG

CAPSULE;ORAL - 0.05MG

CAPSULE;ORAL - 0.0625MG