Details for New Drug Application (NDA): 022450
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The generic ingredient in OFIRMEV is acetaminophen. There are sixty-six drug master file entries for this compound. Ninety-four 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
Suppliers and Packaging for NDA: 022450
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1424 | 51662-1424-1 | 100 mL in 1 VIAL, GLASS (51662-1424-1) |
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| Strength | 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | ⤷ Sign Up | Patent Expiration: | Nov 13, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 13, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 11, 2032 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 022450
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Mallinckrodt Hosp | OFIRMEV | acetaminophen | SOLUTION;INTRAVENOUS | 022450-001 | Nov 2, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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