Labetalol Hydrochloride

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 18 USDMF, 7 CEP/COS, 3 JDMF, 5 EU WC, 12 NDC API, 19 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers, 82 FDA Orange Book, 32 Europe, 11 Canada, 2 Australia, 3 South Africa, 28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 5 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 17 BASF, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 12 Gangwal Chemicals, 5 Ideal Cures, 3 Ingredion Pharma Solutions, 26 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

46 Coating Systems & Additives, 45 Fillers, Diluents & Binders, 32 Direct Compression, 30 Disintegrants & Superdisintegrants, 27 Thickeners and Stabilizers, 25 Granulation, 22 Controlled & Modified Release, 18 Solubilizers, 14 Topical, 14 Lubricants & Glidants, 13 Parenteral, 11 Chewable & Orodispersible Aids, 11 Film Formers & Plasticizers, 11 Co-Processed Excipients, 8 Taste Masking, 7 Emulsifying Agents, 6 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 19 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 10 Regulatory FDF Prices

MARKET PLACE

27 APIs, 11 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 2 Others

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USFDA APPLICATION NUMBER - 18716 / DOSAGE - TABLET;ORAL - 100MG **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
labetalol hydrochloride(UNII: 1GEV3BAW9J) (labetalol - UNII:R5H8897N95)	labetalol hydrochloride	300mg \| 200mg \| 100mg

Inactive Ingredients

Ingredient Name	Alvogen Inc.	Bryant Ranch Prepack	County Line Pharmaceuticals LLC	NuCare Pharmaceuticals, Inc.	REMEDYREPACK INC.	St. Mary's Medical Park Pharmacy	A-S Medication Solutions
FD&C YELLOW NO. 6(H77VEI93A8)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
lactose, unspecified form(J2B2A4N98G)
magnesium stearate(70097M6I30)
sodium benzoate(OJ245FE5EU)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid A8a3c319 211e 4b85 827a 8b4a04496faf Applno 18716 Form Tablet Oral Dosage 100mg - Drug Product Composition: Labetalol Hydrochloride