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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020310
Company: KRAMER

Other Important Information from FDA

Products on NDA 20310

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIZORAL ANTI-DANDRUFF	KETOCONAZOLE	1%	SHAMPOO;TOPICAL	Over-the-counter	None	Yes	Yes

Labels for NDA 020310

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2026	SUPPL-42	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020310Orig1s042lbl.pdf
11/18/2025	SUPPL-41	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020310Orig1s041lbl.pdf
01/26/2025	SUPPL-34	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020310Orig1s034lbl.pdf
07/05/2024	SUPPL-33	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020310Orig1s033lbl.pdf
03/14/2024	SUPPL-32	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020310Orig1s032lbl.pdf
09/29/2023	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020310Orig1s031lbl.pdf
01/19/2023	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020310Orig1s029lbl.pdf
05/13/2022	SUPPL-27	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020310Orig1s027lbl.pdf
04/20/2020	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020310orig1s024lbl.pdf
11/25/2019	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020310Orig1s023lbl.pdf
11/30/2018	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020310s022lbl.pdf

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