Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050344
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STATROL NEOMYCIN SULFATE; POLYMYXIN B SULFATE EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;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
03/12/1974 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
09/28/1999 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/05/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/09/1997 SUPPL-16 Labeling

Label is not available on this site.

11/29/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1993 SUPPL-13 Labeling

Label is not available on this site.

08/08/1984 SUPPL-10 Labeling

Label is not available on this site.

11/23/1983 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1983 SUPPL-8 Labeling

Label is not available on this site.

08/24/1992 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/22/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/13/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/03/1989 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1991 SUPPL-1 Labeling

Label is not available on this site.

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