Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761094
Company: DOMPE FARMACEUTICI

Products on BLA 761094

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXERVATE	CENEGERMIN-BKBJ	0.002%(20MCG/ML)	SOLUTION;OPHTHALMIC	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761094

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761094s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761094Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761094Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2019	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761094s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761094Orig1s001ltr.pdf

Labels for BLA 761094

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761094s001lbl.pdf
08/22/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761094s000lbl.pdf