Details for New Drug Application (NDA): 022450
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NDA 022450 describes OFIRMEV, which is a drug marketed by Mallinckrodt Hosp and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OFIRMEV profile page.
The generic ingredient in OFIRMEV is acetaminophen. There are sixty-six drug master file entries for this compound. Ninety-two suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
The generic ingredient in OFIRMEV is acetaminophen. There are sixty-six drug master file entries for this compound. Ninety-two suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
Summary for 022450
| Tradename: | OFIRMEV |
| Applicant: | Mallinckrodt Hosp |
| Ingredient: | acetaminophen |
| Patents: | 4 |
Medical Subject Heading (MeSH) Categories for 022450
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 2, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 13, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 11, 2032 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 13, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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