Details for New Drug Application (NDA): 040910
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NDA 040910 describes OXYCODONE AND ASPIRIN, which is a drug marketed by Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Epic Pharma Llc, Sun Pharm Industries, and Roxane, and is included in seven NDAs. It is available from one supplier. Additional details are available on the OXYCODONE AND ASPIRIN profile page.
The generic ingredient in OXYCODONE AND ASPIRIN is aspirin; oxycodone hydrochloride; oxycodone terephthalate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; oxycodone hydrochloride; oxycodone terephthalate profile page.
The generic ingredient in OXYCODONE AND ASPIRIN is aspirin; oxycodone hydrochloride; oxycodone terephthalate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; oxycodone hydrochloride; oxycodone terephthalate profile page.
Summary for 040910
| Tradename: | OXYCODONE AND ASPIRIN |
| Applicant: | Epic Pharma Llc |
| Ingredient: | aspirin; oxycodone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 040910
| Mechanism of Action | Cyclooxygenase Inhibitors Full Opioid Agonists |
| Physiological Effect | Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 040910
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE AND ASPIRIN | aspirin; oxycodone hydrochloride | TABLET;ORAL | 040910 | ANDA | Epic Pharma, LLC | 42806-061 | 42806-061-01 | 100 TABLET in 1 BOTTLE (42806-061-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;4.8355MG | ||||
| Approval Date: | Jul 16, 2020 | TE: | AA | RLD: | No | ||||
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