Details for New Drug Application (NDA): 007337
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NDA 007337 describes PERCODAN-DEMI, which is a drug marketed by Endo Operations and is included in one NDA. Additional details are available on the PERCODAN-DEMI profile page.
The generic ingredient in PERCODAN-DEMI 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 PERCODAN-DEMI 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 007337
| Tradename: | PERCODAN-DEMI |
| Applicant: | Endo Operations |
| Ingredient: | aspirin; oxycodone hydrochloride |
| Patents: | 0 |
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 006
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 007
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;4.8355MG | ||||
| Approval Date: | Aug 5, 2005 | TE: | AA | RLD: | Yes | ||||
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