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- 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21610 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)	OXYMORPHONE HYDROCHLORIDE	10mg \| 20mg

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	St Marys Medical Park Pharmacy	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C YELLOW NO. 6(H77VEI93A8)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
METHYLPARABEN(A2I8C7HI9T)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Setid 9c4136e8 C2dc 4ea0 9c65 F2d1c57d1171 Applno 21610 Form Tablet Extended Release Oral Dosage 7 5mg - Drug Product Composition: Oxymorphone Hydrochloride