Promethazine.HCl | 83312 | INJECTABLE;INJECTION | 25MG/ML

Promethazine HCl

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 9 USDMF, 3 CEP/COS, 2 JDMF, 2 EU WC, 14 NDC API, 7 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers, 174 FDA Orange Book, 3 Europe, 4 Canada, 16 South Africa, 22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 25MG/ML, INJECTABLE;INJECTION - 50MG/ML, SYRUP;ORAL - 6.25MG/5ML, SYRUP;ORAL - 5MG/5ML;6.25MG/5ML, SYRUP;ORAL - 10MG/5ML;6.25MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 3 SPI Pharma, 20 DKSH, 2 Pharm-RX Chemical, 6 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 10 Kirsch Pharma, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 11 BASF, 1 Bioplus Life Sciences, 4 CD Formulation, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 12 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 1 Symrise, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

52 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 38 Thickeners and Stabilizers, 26 Parenteral, 25 Direct Compression, 20 Granulation, 20 Solubilizers, 19 Controlled & Modified Release, 18 Film Formers & Plasticizers, 16 Lubricants & Glidants, 16 Taste Masking, 15 Disintegrants & Superdisintegrants, 15 Topical, 11 Co-Processed Excipients, 9 Empty Capsules, 9 Emulsifying Agents, 8 Rheology Modifiers, 7 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

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GLOBAL SALES INFORMATION

36 US Medicaid Prescriptions, 22 Regulatory FDF Prices

MARKET PLACE

37 APIs, 2 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP

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USFDA APPLICATION NUMBER - 83312 / DOSAGE - INJECTABLE;INJECTION - 25MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PROMETHAZINE HYDROCHLORIDE(UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)	PROMETHAZINE HYDROCHLORIDE	25mg in 1

Inactive Ingredients

Ingredient Name	Cardinal Health	REMEDYREPACK INC.	X-GEN Pharmaceuticals, Inc.	Hospira, Inc.
ACETIC ACID(Q40Q9N063P)
CALCIUM CHLORIDE(M4I0D6VV5M)
EDETATE DISODIUM(7FLD91C86K)
EDETATE SODIUM(MP1J8420LU)
MONOTHIOGLYCEROL(AAO1P0WSXJ)
PHENOL(339NCG44TV)
SODIUM ACETATE(4550K0SC9B)
SODIUM METABISULFITE(4VON5FNS3C)
WATER(059QF0KO0R)

Setid 10d38e48 21d9 4c56 9532 5de06c1d0ad5 Applno 83312 Form Injectable Injection Dosage 25mg Ml - Drug Product Composition: Promethazine.HCl