Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019757
Company: MERCK

Products on NDA 019757

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHIBROXIN	NORFLOXACIN	0.3%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019757

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/1991	ORIG-1	Approval	Type 3 - New Dosage Form	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
02/05/2001	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19757S10lbl.pdf
10/08/1999	SUPPL-9	Labeling		Label is not available on this site.
02/24/1998	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
07/27/1998	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/24/1995	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/22/1993	SUPPL-5	Labeling		Label is not available on this site.
06/30/1993	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/11/1992	SUPPL-3	Labeling		Label is not available on this site.
04/27/1993	SUPPL-2	Efficacy-New Patient Population		Label is not available on this site.
12/11/1992	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 019757

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2001	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19757S10lbl.pdf