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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022134
Company: ABBVIE

Summary Review

Products on NDA 022134

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LASTACAFT	ALCAFTADINE	0.25%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022134

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2010	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022134s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022134s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2022	SUPPL-9	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022134Orig1s009ltr.pdf
12/10/2021	SUPPL-8	Efficacy-Rx To OTC Switch	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022134Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022134Orig1s008ltr.pdf
06/09/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022134s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022134Orig1s007ltr.pdf
09/30/2015	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022134s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022134Orig1s004ltr.pdf
07/25/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/12/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/04/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022134s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022134Orig1s001ltr.pdf

Labels for NDA 022134

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2021	SUPPL-8	Efficacy-Rx To OTC Switch	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022134Orig1s008lbl.pdf
06/09/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022134s007lbl.pdf
09/30/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022134s004lbl.pdf
12/04/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022134s001lbl.pdf
07/28/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022134s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

LASTACAFT

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION/DROPS;OPHTHALMIC; 0.25%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ALCAFTADINE	ALCAFTADINE	0.25%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	209706	GLAND PHARMA LTD
LASTACAFT	ALCAFTADINE	0.25%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	022134	ABBVIE

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