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Setid 55639e61 8757 11de 8a39 0800200c9a66 Applno 11707 Form Injectable Injection Dosage 1mg Ml - Drug Product Composition: Oxymorphone Hydrochloride

Oxymorphone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 8 USDMF, 3 NDC API, 5 Listed Suppliers

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

75 FDF Dossiers, 75 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 1MG/ML, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

DIGITAL CONTENT

15 News #PharmaBuzz

15 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 17 Regulatory FDF Prices

PATENTS & EXCLUSIVITIES

42 US Patents

42 US Patents

REF. STANDARDS & IMPURITIES

2 Others

2 Others

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USFDA APPLICATION NUMBER - 11707 / DOSAGE - INJECTABLE;INJECTION - 1MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)	OXYMORPHONE HYDROCHLORIDE	1mg in 1

Inactive Ingredients

Ingredient Name	Endo Pharmaceuticals Inc.
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)

Setid 55639e61 8757 11de 8a39 0800200c9a66 Applno 11707 Form Injectable Injection Dosage 1mg Ml - Drug Product Composition: Oxymorphone Hydrochloride

Oxymorphone Hydrochloride

Oxymorphone Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

10 API Suppliers

8 USDMF

3 NDC API

5 Listed Suppliers

DEVELOPMENTS

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

75 FDF Dossiers

75 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 1MG/ML

TABLET, EXTENDED RELEASE;ORAL - 10MG

TABLET, EXTENDED RELEASE;ORAL - 15MG

TABLET, EXTENDED RELEASE;ORAL - 20MG

TABLET, EXTENDED RELEASE;ORAL - 30MG

TABLET, EXTENDED RELEASE;ORAL - 40MG

TABLET, EXTENDED RELEASE;ORAL - 5MG

TABLET, EXTENDED RELEASE;ORAL - 7.5MG

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

DIGITAL CONTENT

15 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions

17 Regulatory FDF Prices

PATENTS & EXCLUSIVITIES

42 US Patents

REF. STANDARDS & IMPURITIES

2 Others

Filters

TABLET, EXTENDED RELEASE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons