Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018057
Company: HQ SPCLT PHARMA

Products on NDA 18057

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

Labels for NDA 018057

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