Lidocaine hydrochloride 0.2% in dextrose 5% in plastic container

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ACTIVE PHARMA INGREDIENTS

78 API Suppliers, 13 USDMF, 10 CEP/COS, 3 JDMF, 6 EU WC, 14 KDMF, 27 NDC API, 39 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

FINISHED DOSAGE FORMULATIONS

559 FDF Dossiers, 228 FDA Orange Book, 208 Europe, 66 Canada, 17 South Africa, 40 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 4%, INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 0.005MG/ML;0.5%, INJECTABLE;INJECTION - 0.005MG/ML;1%, INJECTABLE;INJECTION - 0.005MG/ML;1.5%, INJECTABLE;INJECTION - 0.005MG/ML;2%, INJECTABLE;INJECTION - 0.01MG/ML;1%, INJECTABLE;INJECTION - 0.01MG/ML;2%, INJECTABLE;INJECTION - 0.02MG/ML;2%, INJECTABLE;INJECTION - 0.5%, INJECTABLE;INJECTION - 1%, INJECTABLE;INJECTION - 1.5%, INJECTABLE;INJECTION - 2%, INJECTABLE;INJECTION - 1%, INJECTABLE;INJECTION - 2%, INJECTABLE;INJECTION - 1%, INJECTABLE;SPINAL - 5%, JELLY;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%, INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Evonik, 6 Rochem International Inc, 12 SPI Pharma, 18 DKSH, 1 PMC Isochem, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 18 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Capital Farma, 15 Kirsch Pharma, 1 ACG Worldwide, 22 Actylis, 3 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 43 BASF, 1 Bioplus Life Sciences, 1 BioSpectra, 5 CD Formulation, 1 Clariant, 17 Corel Pharma Chem, 3 Doshion Polyscience, 2 Esteem Industries, 5 Finar, 13 Gangwal Chemicals, 3 Ideal Cures, 2 Ingredion Pharma Solutions, 10 Kerry, 1 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 9 Lubrizol Life Science Health, 9 Microlex e.U, 3 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 21 Roquette, 25 Seppic, 3 Shandong Focus Biotechnology Co., Ltd, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 4 Sigachi Industries, 2 Symrise, 3 The Dow Chemical Company, 2 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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PATENTS & EXCLUSIVITIES

4 US Patents

4 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM

1 EDQM

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USFDA APPLICATION NUMBER - 10417 / DOSAGE - INJECTABLE;INJECTION - 4%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE(UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	40mg in 1

Inactive Ingredients

Ingredient Name	APP Pharmaceuticals, LLC	Cardinal Health
Hydrochloric Acid(QTT17582CB)
METHYLPARABEN(A2I8C7HI9T)
SODIUM CHLORIDE(451W47IQ8X)
Sodium Hydroxide(55X04QC32I)
WATER(059QF0KO0R)

Drug Product Composition: Lidocaine hydrochloride 0.2% in dextrose 5% in plastic container