RANITIDINE HYDROCHLORIDE | A074655 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara FDA-2018-P-0034 · 4 docket documents The law firm Hyman, Phelps & McNamara filed this citizen petition requesting that the FDA designate Ranitidine Hydrochloride Capsules, 300 mg, approved under ANDA 075742, as a Reference Standard in the Orange Book to facilitate generic drug competition, as the current reference standard approved und | 505(q) | 2018-01-03 | Denied | Hyman, Phelps & McNamara |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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