Details for New Drug Application (NDA): 085106
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NDA 085106 describes PERCOCET, which is a drug marketed by Endo Operations and Vintage Pharms Llc and is included in three NDAs. It is available from two suppliers. Additional details are available on the PERCOCET profile page.
The generic ingredient in PERCOCET is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
The generic ingredient in PERCOCET is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 085106
| Tradename: | PERCOCET |
| Applicant: | Endo Operations |
| Ingredient: | acetaminophen; oxycodone hydrochloride |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Yes | |||||
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