CARBOPLATIN | N020452 | CORDENPHARMA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Qilu Pharma, Inc. as the US Agent of Qilu Pharmaceutica... FDA-2017-P-2231 · 3 docket documents Qilu Pharma, Inc. as the US Agent of Qilu Pharmaceutical Co., Ltd. submitted this petition on April 7, 2017 requesting that the FDA designate Carboplatin Injection in multiple strengths (50 MG/5ML, 150 MG/15ML, 450 MG/45ML, and 600 MG/60ML) from PHARMACHEMIE BV with application number A077269 as an | 505(q) | 2017-04-10 | Withdrawn | Qilu Pharma, Inc. as the US Agent of Qilu Pharmaceutical Co., Ltd |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2005-P-0266 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Carboplatin Injection 10 mg/mL in a 1000 mg/100 mL multiple-dose vial suitable for consideration in an Abbreviated New Drug Application under Section 505(j)(2)(C), with Paraplatin (carboplatin | Other | 2009-10-13 | Granted | Lachman Consultant Services, Inc. |
OncoTherapies Limited - Citizen Petition FDA-2008-P-0660 · 2 docket documents OncoTherapies Limited filed this citizen petition requesting that the FDA declare Carboplatin Injection 10 mg/mL in a 1000 mg/100 mL multiple-dose vial suitable for submission as an ANDA under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, referencing Bristol Myers Squibb's Parapla | Other | 2008-12-31 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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