PANTOPRAZOLE SODIUM | N020988 | WYETH PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Emcure Pharmaceuticals USA INC. FDA-2014-P-0142 Emcure Pharmaceuticals USA Inc. filed this citizen petition on January 21, 2014, requesting that the FDA accept an Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection USP (equivalent to 40 mg pantoprazole) referencing a discontinued formulation of Protonix I.V. that require | Other | 2014-02-06 | Denied | Emcure Pharmaceuticals USA INC. |
Citizens Petition from Sun Pharmaceutical Industries Ltd. FDA-2005-P-0082 Sun Pharmaceutical Industries Ltd. submitted this citizen petition under section 505(j)(2)(C) requesting that the FDA determine that the discontinued formulation of Protonix I.V. for injection containing pantoprazole sodium (40 mg per vial requiring storage at 2°C-8°C) is suitable for submission as | 505(q) | 2008-04-22 | Open | Sun Pharmaceutical Industries Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NPP | Aug 12, 2027 | Active |