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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021275
Company: ABBVIE

Products on NDA 021275

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMIGAN	BIMATOPROST	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021275

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2001	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21275lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan0.03percentOpthalmisSolution_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2022	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021275s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021275Orig1s029ltr.pdf
10/15/2020	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021275s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021275Orig1s028ltr.pdf
07/29/2017	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021275s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021275Orig1s027ltr.pdf
09/29/2014	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021275s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021275Orig1s026ltr.pdf
02/28/2013	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
03/15/2012	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021275s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021275Orig1s023ltr.pdf
03/11/2011	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s022lbl.pdf
11/10/2003	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scs014,slr015ltr.pdf
11/10/2003	SUPPL-14	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scs014,slr015ltr.pdf
06/22/2006	SUPPL-13	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021275s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021275s013LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021275_S013_LUMIGAN.pdf
08/25/2003	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scp010,slr012ltr.pdf
03/11/2011	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s011lbl.pdf
08/25/2003	SUPPL-10	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scp010,slr012ltr.pdf
08/26/2002	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21275slr006ltr.pdf
04/12/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/2002	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/07/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021275

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2022	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021275s029lbl.pdf
10/15/2020	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021275s028lbl.pdf
07/29/2017	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021275s027lbl.pdf
09/29/2014	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021275s026lbl.pdf
03/15/2012	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021275s023lbl.pdf
03/11/2011	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s022lbl.pdf
03/11/2011	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s011lbl.pdf
06/22/2006	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021275s013lbl.pdf
11/10/2003	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf
11/10/2003	SUPPL-14	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf
08/25/2003	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf
08/25/2003	SUPPL-10	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf
08/26/2002	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf
03/16/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21275lbl.pdf

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