OMEPRAZOLE MAGNESIUM | N021229 | ASTRAZENECA PHARMACEUTICALS LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
AUROBINDO PHARMA LIMITED et al v. ASTRAZENECA AB et al 2 patentsANDA 206877omeprazole magnesium | D.N.J. | 2016-08-18 | Terminated 2017-09-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Proctor & Gamble Company - Citizen Petition FDA-2013-P-1286 · 3 docket documents Procter & Gamble Company filed this citizen petition requesting that the FDA continue requiring consistent labeling across all over-the-counter proton pump inhibitors approved for frequent heartburn treatment, substantially equivalent to that approved for Prilosec OTC, including statements about del | 505(q) | 2013-11-14 | Denied | — |
Mattingly, Stanger & Malur, P.C. - Citizen Petition FDA-2003-P-0224 · 4 docket documents The law firm Mattingly, Stanger & Malur, P.C. filed this citizen petition under 21 CFR 10.30 and 10.35(b) requesting that the FDA amend its NDA approval for Prilosec OTC (omeprazole magnesium), a nonprescription heartburn treatment approved on June 20, 2003, to require marketing under a different br | Other | 2009-01-05 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.