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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214581
Company: NOVITIUM PHARMA

Products on NDA 214581

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOVUNA	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET;ORAL	Prescription	None	Yes	No
SOVUNA	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214581

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214581s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214581Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214581Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214581s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214581Orig1s007ltr.pdf
09/14/2023	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214581s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214581Orig1s006ltr.pdf
01/12/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214581s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214581Orig1s004ltr.pdf

Labels for NDA 214581

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2023	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214581s006lbl.pdf
09/14/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214581s006lbl.pdf
07/24/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214581s007lbl.pdf
01/12/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214581s004lbl.pdf
01/14/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214581s000lbl.pdf

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