CISPLATIN | N018057 | HQ SPECIALTY PHARMA CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition A from PHARMACHEMIE B.V. FDA-1988-P-0242 Pharmachemie B.V., a Netherlands-based pharmaceutical manufacturer, filed an ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting approval to submit an Abbreviated New Drug Application for Cisplatin Injection 0.5 mg/mL in 20 mL vials, which would | Other | 2017-06-28 | Withdrawn | — |
Citizen Petition B from PHARMACHEMIE B.V. FDA-1988-P-0242 Pharmachemie B.V. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting permission to submit an abbreviated new drug application for cisplatin injection 0.5 mg/mL in 100 mL vials, which would contain the same 50 mg active ingredient as the l | Other | 2017-06-28 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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