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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050810
Company: THEA PHARMA

Products on NDA 050810

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZASITE	AZITHROMYCIN	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050810

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050810lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050810s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/050810_azasite_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2021	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050810Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050810Orig1s019ltr.pdf
03/12/2013	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/05/2012	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050810s014ltr.pdf
10/16/2012	SUPPL-12	Manufacturing (CMC)	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/050810Orig1s012.pdf
03/31/2011	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050810s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050810s007ltr.pdf
05/06/2009	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf
05/06/2009	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf
05/06/2009	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050810s001,050810s002,s005ltr.pdf

Labels for NDA 050810

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2021	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050810Orig1s019lbl.pdf
10/16/2012	SUPPL-12	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s012lbl.pdf
07/05/2012	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050810s014lbl.pdf
03/31/2011	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050810s007lbl.pdf
04/27/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050810lbl.pdf

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