NIFEDIPINE | N020198 | NORWICH PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Yabao Pharmaceutical Co. Ltd BJ FDA-2017-P-6214 Yabao Pharmaceutical Co. Ltd BJ filed this petition pursuant to Section 505(j) of the FD&C Act requesting that the FDA amend the Orange Book to designate ANDA #201071, nifedipine tablets extended release 60 mg manufactured by Mylan Pharmaceuticals Inc., as an additional Reference Standard for nifedi | Other | 2017-10-20 | Denied | Yabao Pharmaceutical Co. Ltd BJ |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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