Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050628
Company: HARROW EYE

Products on NDA 050628

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRASONE	FLUOROMETHOLONE ACETATE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050628

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/1989	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/09/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/07/2001	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50628S1lbl.pdf

Labels for NDA 050628

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2001	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50628S1lbl.pdf