CALCIUM CARBONATE; RISEDRONATE SODIUM | N021823 | WARNER CHILCOTT CO LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Aurobindo Pharmaceuticals, Ltd., (EAS Consultant Group, LLC) - Citizen petition FDA-2010-P-0059 · 4 docket documents Aurobindo Pharmaceuticals Limited, represented by EAS Consulting Group LLC, filed this petition on January 21, 2010, requesting that the FDA determine whether Actonel with Calcium (Copackaged) (Risedronate Sodium and Calcium Carbonate), NDA 021823, manufactured by Procter and Gamble, was withdrawn f | 505(q) | 2010-02-16 | Granted | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2010-P-0051 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner determine whether Actonel with Calcium (risedronate sodium and calcium carbonate copackaged) Tablets, 35 mg/500 mg (NDA 021823), manufactured by Procter and Gamble, was voluntaril | 505(q) | 2010-01-25 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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