Details for New Drug Application (NDA): 089775
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NDA 089775 describes ROXICET 5/500, which is a drug marketed by Roxane and is included in one NDA. Additional details are available on the ROXICET 5/500 profile page.
The generic ingredient in ROXICET 5/500 is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
The generic ingredient in ROXICET 5/500 is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 089775
| Tradename: | ROXICET 5/500 |
| Applicant: | Roxane |
| Ingredient: | acetaminophen; oxycodone hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG;5MG | ||||
| Approval Date: | Jan 12, 1989 | TE: | RLD: | No | |||||
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