Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062721
Company: ALCON PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/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
11/17/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/16/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/07/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/02/1999 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/07/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/25/1998 SUPPL-9 Labeling

Label is not available on this site.

04/16/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/27/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-6 Labeling

Label is not available on this site.

10/14/1993 SUPPL-5 Labeling

Label is not available on this site.

10/31/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/12/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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