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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209875
Company: LUPIN LTD

Products on NDA 209875

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIKITA	PITAVASTATIN SODIUM	EQ 1MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
NIKITA	PITAVASTATIN SODIUM	EQ 2MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
NIKITA	PITAVASTATIN SODIUM	EQ 4MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209875

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2017	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209875s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209875Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209875Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209875s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209875Orig1s003ltr.pdf
09/25/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209875s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209875orig1s002ltr.pdf
05/05/2020	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209875s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209875Orig1s001ltr.pdf

Labels for NDA 209875

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209875s003lbl.pdf
09/25/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209875s002lbl.pdf
05/05/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209875s001lbl.pdf
08/04/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209875s000lbl.pdf

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