Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050456
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/ML;16,250 UNITS/ML 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
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
09/09/1997 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-456S020.pdf
11/01/1995 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1989 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/15/1987 SUPPL-16 Labeling

Label is not available on this site.

05/15/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/08/1984 SUPPL-14 Labeling

Label is not available on this site.

07/28/1983 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/11/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1978 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/09/1978 SUPPL-9 Labeling

Label is not available on this site.

02/09/1978 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/01/1977 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/03/1976 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/01/1976 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/28/1993 SUPPL-3 Labeling

Label is not available on this site.

12/31/1991 SUPPL-1 Labeling

Label is not available on this site.

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