Details for New Drug Application (NDA): 090964
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The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 090964
Tradename: | OXYMORPHONE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | oxymorphone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090964
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 090964
Suppliers and Packaging for NDA: 090964
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 090964 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0283 | 0054-0283-25 | 100 TABLET in 1 BOTTLE (0054-0283-25) |
OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 090964 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0284 | 0054-0284-25 | 100 TABLET in 1 BOTTLE (0054-0284-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 27, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 27, 2010 | TE: | AB | RLD: | No |
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