Details for New Drug Application (NDA): 077821
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NDA 077821 describes PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, which is a drug marketed by Able, Actavis Elizabeth, Cornerstone, Halsey, Ivax Sub Teva Pharms, Mallinckrodt, Mirror Pharms, Mutual Pharm, Mylan, Mylan Pharms Inc, Sandoz, Superpharm, Teva, Vintage Pharms, Watson Labs, Watson Labs Florida, and Wockhardt Ltd, and is included in twenty-six NDAs. 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-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene napsylate profile page.
The generic ingredient in PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN is acetaminophen; propoxyphene napsylate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene napsylate profile page.
Summary for 077821
| Tradename: | PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN |
| Applicant: | Mirror Pharms |
| Ingredient: | acetaminophen; propoxyphene napsylate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 650MG;100MG | ||||
| Approval Date: | Feb 11, 2008 | TE: | RLD: | No | |||||
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