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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214028
Company: ABBVIE

Products on NDA 214028

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VUITY	PILOCARPINE HYDROCHLORIDE	1.25%	SOLUTION;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214028

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214028s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214028Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214028Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2023	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214028Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214028Orig1s003ltr.pdf
03/28/2023	SUPPL-2	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214028Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214028Orig1s002ltr.pdf
08/16/2022	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214028s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214028Orig1s001ltr.pdf

Labels for NDA 214028

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2023	SUPPL-2	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214028Orig1s002lbl.pdf
03/08/2023	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214028Orig1s003lbl.pdf
08/16/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214028s001lbl.pdf
10/28/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214028s000lbl.pdf

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