NISOLDIPINE | A091001 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Emcure Pharmaceuticals USA, Inc FDA-2014-P-0549 · 4 docket documents Emcure Pharmaceuticals USA, Inc. filed this citizen petition on April 28, 2014, requesting that the FDA determine that Shionogi, Inc. discontinued marketing SULAR (nisoldipine) extended-release tablets 25.5 mg under NDA 20-356 for reasons unrelated to safety and efficacy, and that the FDA permit Emc | 505(q) | 2014-05-07 | Granted | Emcure Pharmaceuticals USA, Inc |
Mylan Pharmaceuticals, Inc. - Citizen Petition FDA-2008-P-0318 · 2 docket documents Mylan Pharmaceuticals, Inc. filed this citizen petition pursuant to 21 U.S.C. § 355(q) requesting that the FDA immediately determine that Sciele Pharma discontinued its SULAR (nisoldipine) Extended-Release Tablets in 10 mg, 20 mg, 30 mg, and 40 mg strengths under NDA 20-356 for reasons unrelated to | 505(q) | 2008-06-02 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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