Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019757
Company: MERCK
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
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.

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

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