Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022278
Company: DORC

Products on NDA 022278

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEMBRANEBLUE	TRYPAN BLUE	0.15%	SOLUTION;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022278

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/2009	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022278lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022278s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022278_membraneblue_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2014	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022278s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022278Orig1s003ltr.pdf
08/25/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022278

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2014	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022278s003lbl.pdf
02/20/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022278lbl.pdf