ACETAMINOPHEN | N022450 | MALLINCKRODT HOSP PRODUCTS IP LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Mallinckrodt Hospital Products IP Limited et al v. Baxter Healthcare Corporation 5 patentsANDA 214331acetaminophen | D. Del. | 2020-03-27 | Terminated 2020-04-30 | — |
Mallinckrodt Hospital Products IP Limited et al v. Altan Pharma Ltd. 4 patentsAcetaminophen (paracetamol) | D. Del. | 2019-03-22 | Terminated 2019-08-29 | — |
Mallinckrodt IP Unlimited Company et al v. Aurobindo Pharma USA, Inc. 3 patentsANDA 210969acetaminophen (paracetamol) | D. Del. | 2017-12-29 | Terminated 2018-05-30 | — |
| D. Del. | 2017-05-31 | Terminated 2018-10-05 | — | |
| D. Del. | 2017-04-03 | Terminated 2018-10-05 | — | |
| N.D. Ill. | 2013-01-18 | Terminated 2013-03-12 | — | |
| CASD | 2013-01-17 | Terminated 2014-08-08 | — | |
Cadence Pharmaceuticals, Inc. et al v. Paddock Laboratories, Inc. et al 2 patentsANDA 202605Acetaminophen | MND | 2011-08-19 | Terminated 2011-11-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2023-P-4335 The law firm Hyman, Phelps & McNamara submitted this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Acetaminophen Injection in 500 mg/50 mL and 650 mg/65 mL strengths suita | Suitability | 2023-10-05 | Open | HYMAN |
Attachment 2 - Prescribing Information for OFIRMEV (acetaminophen) Injection ... FDA-2023-P-4296 Lachman Consultant Services, Inc. filed a citizen petition regarding OFIRMEV (acetaminophen) injection, requesting FDA review of the suitability of the prescribing information based on updated safety and clinical data available as of February 2020. | Suitability | 2023-10-02 | Open | Lachman Consultant Services |
Attachment 1 - FDA Orange Book page forOFIRMEV (acetaminophen) Injection RE S... FDA-2023-P-4296 I cannot provide a summary of this FDA citizen petition because the document provided contains only a title and reference line without substantive content describing who filed the petition, what specific action was requested, or the detailed basis for the petition. To accurately summarize the petiti | Suitability | 2023-10-02 | Open | Lachman Consultant Services |
Suitability Petition from Lachman Consultant Services, Inc. FDA-2023-P-4296 Lachman Consultant Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Acetaminophen Injection in 500 mg/50 mL and 650 mg/65 mL strengths suitable for submission in an ANDA, referencing OFIRMEV (acetaminophen) Injection 1 g/100 mL | Suitability | 2023-10-02 | Open | Lachman Consultant Services |
Citizen Petition from Nines Consult Pharma LLC FDA-2022-P-1982 Nines Consult Pharma LLC filed this citizen petition requesting that the FDA determine whether OFIRMEV (acetaminophen) injection 1000 mg/100 mL under NDA 022450, held by Mallinckrodt Hosp Products IP Ltd., was withdrawn from sale for safety or effectiveness reasons pursuant to 21 C.F.R. § 314.161. T | Other | 2022-08-23 | Withdrawn | Nines Consult Pharma LLC |
Suitability Petition from Hyman, Phelps & McNamara, PC FDA-2020-P-1071 Hyman, Phelps & McNamara, PC filed this suitability petition on behalf of a client requesting that the FDA declare Acetaminophen Injection in 500 mg/50 mL and 650 mg/65 mL strengths suitable for submission in an ANDA under Section 505(j)(2)(C) of the FDC Act, with OFIRMEV (acetaminophen) Injection 1 | Suitability | 2020-03-11 | Open | Hyman |
Attachment 2 Prescribing Information for OFIRMEV re Suitability Petition from... FDA-2020-P-1071 I appreciate your request, but the document you've provided only contains a title and header information without substantive content about the petition's details. To summarize the citizen petition accurately with specific information about who filed it, which drug was involved, and what regulatory a | Suitability | 2020-03-11 | Open | Hyman |
Attachment 1 FDA Orange Book page for OFIRMEV re Suitability Petition from Hy... FDA-2020-P-1071 I cannot provide a summary of this petition because the document provided contains only a title and reference information without the actual petition content, specific details about the requested action, drug composition, or regulatory mechanism involved. To accurately summarize the petition as requ | Suitability | 2020-03-11 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.