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Details for New Drug Application (NDA): 020932
NDA 020932 describes ROXICODONE, which is a drug marketed by Roxane and Specgx Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the ROXICODONE profile page.
The generic ingredient in ROXICODONE is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
The generic ingredient in ROXICODONE is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 020932
| Tradename: | ROXICODONE |
| Applicant: | Roxane |
| Ingredient: | oxycodone hydrochloride |
| Patents: | 0 |
| Therapeutic Class: | Analgesics |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 26, 1998 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Oct 26, 1998 | TE: | RLD: | No | |||||
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