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Details for New Drug Application (NDA): 075738

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NDA 075738 describes PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, which is a drug marketed by Halsey, Watson Labs Florida, Actavis Elizabeth, Mutual Pharm, Superpharm, Teva, Mirror Pharms, Able, Mallinckrodt, Cornerstone, Sandoz, Vintage Pharms, Mylan Pharms Inc, Ivax Sub Teva Pharms, Wockhardt Ltd, Mylan, and Watson Labs, and is included in twenty-six NDAs. It is available from seven suppliers. Additional details are available on the PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN profile page.

The generic ingredient in PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN is acetaminophen; propoxyphene napsylate. There are sixty-five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acetaminophen; propoxyphene napsylate profile page.

Summary for NDA: 075738

Tradename:
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Applicant:
Mallinckrodt
Ingredient:
acetaminophen; propoxyphene napsylate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 075738

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 075738

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
acetaminophen; propoxyphene napsylate
TABLET;ORAL 075738 ANDA RedPharm Drug Inc. 67296-0104 67296-0104-1 15 TABLET in 1 BOTTLE (67296-0104-1)
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
acetaminophen; propoxyphene napsylate
TABLET;ORAL 075738 ANDA RedPharm Drug Inc. 67296-0105 67296-0105-1 15 TABLET in 1 BOTTLE (67296-0105-1)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength650MG;100MG
Approval Date:Feb 2, 2001TE:RLD:No


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