Details for New Drug Application (NDA): 087463
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NDA 087463 describes OXYCET, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the OXYCET profile page.
The generic ingredient in OXYCET 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 OXYCET 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 087463
| Tradename: | OXYCET |
| Applicant: | Specgx Llc |
| Ingredient: | acetaminophen; oxycodone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 087463
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 087463
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYCET | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 087463 | ANDA | SpecGx LLC | 0406-0512 | 0406-0512-01 | 100 TABLET in 1 BOTTLE (0406-0512-01) |
| OXYCET | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 087463 | ANDA | SpecGx LLC | 0406-0512 | 0406-0512-05 | 500 TABLET in 1 BOTTLE (0406-0512-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
| Approval Date: | Dec 7, 1983 | TE: | AA | RLD: | No | ||||
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