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Setid 5348515d 7e6b 432c 9a98 6ec8103e2cad Applno 21038 Form Injectable Injection Dosage Eq 400mcg Base 100ml Eq 4mcg Base Ml - Drug Product Composition: Dexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

62 API Suppliers, 20 USDMF, 5 JDMF, 3 EU WC, 15 KDMF, 20 NDC API, 8 VMF, 30 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

81 Drugs in Development

81 Drugs in Development

FINISHED DOSAGE FORMULATIONS

153 FDF Dossiers, 61 FDA Orange Book, 49 Europe, 17 Canada, 9 South Africa, 17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML), INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

RELATED EXCIPIENT COMPANIES

2 Kirsch Pharma, 2 Actylis

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 56 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Regulatory FDF Prices, 4 Annual Reports

MARKET PLACE

23 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

72 US Patents, 9 US Exclusivities, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

2 Others

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USFDA APPLICATION NUMBER - 21038 / DOSAGE - INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXMEDETOMIDINE HYDROCHLORIDE(UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)	DEXMEDETOMIDINE	100ug in 1

Inactive Ingredients

Ingredient Name	Baxter Healthcare Company	Athenex Pharmaceutical Division, LLC.	General Injectables and Vaccines, Inc.	Hikma Pharmaceuticals USA Inc.	Jiangsu Hengrui Medicine Co., Ltd.	Mylan Institutional LLC	Sandoz Inc.
ACETIC ACID(Q40Q9N063P)
SODIUM ACETATE(4550K0SC9B)
SODIUM CHLORIDE(451W47IQ8X)
WATER(059QF0KO0R)

Setid 5348515d 7e6b 432c 9a98 6ec8103e2cad Applno 21038 Form Injectable Injection Dosage Eq 400mcg Base 100ml Eq 4mcg Base Ml - Drug Product Composition: Dexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

62 API Suppliers

20 USDMF

5 JDMF

3 EU WC

15 KDMF

20 NDC API

8 VMF

30 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

81 Drugs in Development

FINISHED DOSAGE FORMULATIONS

153 FDF Dossiers

61 FDA Orange Book

49 Europe

17 Canada

9 South Africa

17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

RELATED EXCIPIENT COMPANIES

2 Kirsch Pharma

2 Actylis

DIGITAL CONTENT

2 Data Compilation #PharmaFlow

56 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

4 Regulatory FDF Prices

4 Annual Reports

MARKET PLACE

23 APIs

8 FDF Dossiers

PATENTS & EXCLUSIVITIES

72 US Patents

9 US Exclusivities

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

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