Labetalol Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 19 USDMF, 6 CEP/COS, 4 JDMF, 4 EU WC, 13 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

10 API Suppliers

10 API Suppliers

FINISHED DOSAGE FORMULATIONS

128 FDF Dossiers, 77 FDA Orange Book, 12 Europe, 11 Canada, 2 Australia, 2 South Africa, 24 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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 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, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 36 Direct Compression, 31 Disintegrants & Superdisintegrants, 28 Controlled & Modified Release, 24 Thickeners and Stabilizers, 20 Granulation, 18 Solubilizers, 16 Co-Processed Excipients, 15 Lubricants & Glidants, 13 Topical, 12 Parenteral, 12 Film Formers & Plasticizers, 9 Chewable & Orodispersible Aids, 7 Taste Masking, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

12 Finished Drug Prices

12 Finished Drug Prices

MARKET PLACE

23 APIs, 11 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 2 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 18716 / DOSAGE - TABLET;ORAL - 200MG **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)

Drug Product Composition: Labetalol Hydrochloride