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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210428
Company: SPIL

Products on NDA 210428

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KAPSPARGO SPRINKLE	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
KAPSPARGO SPRINKLE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
KAPSPARGO SPRINKLE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
KAPSPARGO SPRINKLE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210428

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s000lblReplacement.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210428Orig1s000Replacementltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210428Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/14/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210428s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210428Orig1s006ltr.pdf
05/14/2018	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf

Labels for NDA 210428

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/14/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210428s006lbl.pdf
05/14/2018	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf
05/14/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf
01/26/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s000lblReplacement.pdf

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