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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022369
Company: ABBVIE

Summary Review

Products on NDA 022369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LATISSE	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022369lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022369s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022369_latisse_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022369s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022369s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022369Orig1s014ltr.pdf
09/29/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022369s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022369Orig1s012ltr.pdf
07/29/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022369s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022369Orig1s011ltr.pdf
09/04/2014	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022369Orig1s008,s010ltr.pdf
11/01/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/04/2014	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022369Orig1s008s,010ltr.pdf
03/13/2013	SUPPL-7	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022369s007lbl.pdf
01/31/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/29/2012	SUPPL-5	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022369s005lbl.pdf
09/07/2011	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022369s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022369s004ltr.pdf
09/07/2011	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022369

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022369s014lbl.pdf
09/29/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022369s012lbl.pdf
07/29/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022369s011lbl.pdf
09/04/2014	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf
09/04/2014	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022369s008s010lbl.pdf
03/13/2013	SUPPL-7	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022369s007lbl.pdf
03/29/2012	SUPPL-5	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022369s005lbl.pdf
09/07/2011	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022369s004lbl.pdf
12/24/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022369lbl.pdf

Therapeutic Equivalents for NDA 022369

LATISSE

SOLUTION/DROPS;TOPICAL; 0.03%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	No	AT	210515	ALEMBIC
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	No	AT	201894	APOTEX
BIMATOPROST	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	No	AT	202719	SANDOZ
LATISSE	BIMATOPROST	0.03%	SOLUTION/DROPS;TOPICAL	Prescription	Yes	AT	022369	ABBVIE

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