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Details for New Drug Application (NDA): 040255

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NDA 040255 describes OXYCODONE AND ASPIRIN, which is a drug marketed by Watson Labs, Sun Pharm Inds, Mayne Pharma Inc, Actavis Labs Fl Inc, and Roxane, and is included in six NDAs. It is available from four suppliers. Additional details are available on the OXYCODONE AND ASPIRIN profile page.

The generic ingredient in OXYCODONE AND ASPIRIN is aspirin; oxycodone hydrochloride. There are twenty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aspirin; oxycodone hydrochloride profile page.

Summary for NDA: 040255

Tradename:
OXYCODONE AND ASPIRIN
Applicant:
Watson Labs
Ingredient:
aspirin; oxycodone hydrochloride; oxycodone terephthalate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040255

Suppliers and Packaging for NDA: 040255

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ASPIRIN
aspirin; oxycodone hydrochloride; oxycodone terephthalate
TABLET;ORAL 040255 ANDA Physicians Total Care, Inc. 54868-2094 54868-2094-0 20 TABLET in 1 BOTTLE (54868-2094-0)
OXYCODONE AND ASPIRIN
aspirin; oxycodone hydrochloride; oxycodone terephthalate
TABLET;ORAL 040255 ANDA Physicians Total Care, Inc. 54868-2094 54868-2094-1 30 TABLET in 1 BOTTLE (54868-2094-1)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;4.5MG;0.38MG
Approval Date:Feb 27, 1998TE:RLD:No


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