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FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

Data Compilation
#PharmaFlow

Stock Recap
#PipelineProspector

Medetomidine HCl

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 21 USDMF, 5 JDMF, 3 EU WC, 14 KDMF, 18 NDC API, 8 VMF, 30 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

113 Drugs in Development

113 Drugs in Development

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers, 61 FDA Orange Book, 100 Europe, 16 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

3 Data Compilation #PharmaFlow, 57 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Annual Reports

MARKET PLACE

23 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

72 US Patents, 11 US Exclusivities, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

2 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
29/01/2026	Fermion Oy	Finland	FERMION OY	13810	DEXMEDETOMIDINE HYDROCHLORIDE	1998-10-30	Active	II	Complete	2021-08-31	2021-08-26
29/01/2026	ChemWerth Inc	U.S.A	CHEMWERTH INC	24202	DEXMEDETOMIDINE HCL	2011-12-15	Active	II	Complete	2013-03-27	2012-12-17

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Medetomidine HCl

Medetomidine HCl

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers

21 USDMF

5 JDMF

3 EU WC

14 KDMF

18 NDC API

8 VMF

30 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

113 Drugs in Development

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers

61 FDA Orange Book

100 Europe

16 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

3 Data Compilation #PharmaFlow

57 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

4 Annual Reports

MARKET PLACE

23 APIs

8 FDF Dossiers

PATENTS & EXCLUSIVITIES

72 US Patents

11 US Exclusivities

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

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