Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213260
Company: CMP DEV LLC

Products on NDA 213260

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATORVALIQ	ATORVASTATIN CALCIUM	20MG/5ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2023	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213260s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213260Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/213260Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2024	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213260s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213260Orig1s002ltr.pdf

Labels for NDA 213260

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213260s002lbl.pdf
02/01/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213260s000lbl.pdf