Details for New Drug Application (NDA): 090177
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The generic ingredient in OXYCODONE AND ACETAMINOPHEN 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 090177
Tradename: | OXYCODONE AND ACETAMINOPHEN |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | acetaminophen; oxycodone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090177
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 090177
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 090177 | ANDA | Mayne Pharma Inc. | 68308-475 | 68308-475-47 | 10 BLISTER PACK in 1 CARTON (68308-475-47) / 10 TABLET in 1 BLISTER PACK |
OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 090177 | ANDA | Mayne Pharma Inc. | 68308-480 | 68308-480-47 | 10 BLISTER PACK in 1 CARTON (68308-480-47) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;2.5MG | ||||
Approval Date: | Oct 20, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;5MG | ||||
Approval Date: | Oct 20, 2008 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;7.5MG | ||||
Approval Date: | Oct 20, 2008 | TE: | RLD: | No |
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