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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022221
Company: THEA PHARMA

Summary Review

Products on NDA 022221

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AKTEN	LIDOCAINE HYDROCHLORIDE	3.5%	GEL;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022221

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022221lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022221s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022221_akten_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022221s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2025	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022221s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022221Orig1s011ltr.pdf
02/28/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022221s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022221Orig1s008ltr.pdf
03/11/2014	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022221s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022221Orig1s005ltr.pdf
12/07/2012	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022221s002lbl.pdf

Labels for NDA 022221

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2025	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022221s011lbl.pdf
02/28/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022221s008lbl.pdf
03/11/2014	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022221s005lbl.pdf
12/07/2012	SUPPL-2	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022221s002lbl.pdf
10/07/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022221lbl.pdf

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