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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022184
Company: ABBVIE

Summary Review

Products on NDA 022184

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMIGAN	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022184

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2010	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/2010/022184s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022184_lumigan_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022184Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022184s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022184Orig1s009ltr.pdf
09/29/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022184s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022184Orig1s008ltr.pdf
07/29/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022184s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022184Orig1s006ltr.pdf
09/29/2014	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022184s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022184Orig1s005ltr.pdf
09/19/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/22/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/15/2012	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022184s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022184s001ltr.pdf

Labels for NDA 022184

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022184s009lbl.pdf
09/29/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022184s008lbl.pdf
07/29/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022184s006lbl.pdf
09/29/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022184s005lbl.pdf
03/15/2012	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022184s001lbl.pdf
08/31/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022184s000lbl.pdf

Therapeutic Equivalents for NDA 022184

LUMIGAN

SOLUTION/DROPS;OPHTHALMIC; 0.01%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIMATOPROST	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	217289	AMNEAL
BIMATOPROST	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AB	218196	MANKIND PHARMA
LUMIGAN	BIMATOPROST	0.01%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AB	022184	ABBVIE

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