Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018057
Company: HQ SPCLT PHARMA
Company: HQ SPCLT PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CISPLATIN | CISPLATIN | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
CISPLATIN | CISPLATIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
PLATINOL | CISPLATIN | 10MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
PLATINOL-AQ | CISPLATIN | 0.5MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/24/2022 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018057s092lbl.pdf | |
02/22/2019 | SUPPL-89 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018057s089lbl.pdf | |
02/26/2015 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf | |
12/29/2011 | SUPPL-81 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf | |
08/26/2011 | SUPPL-80 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf | |
09/02/2010 | SUPPL-79 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf |