Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062714
Company: ALCON PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/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
07/21/1986 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
02/19/1999 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/03/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/16/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/27/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/09/1994 SUPPL-7 Labeling

Label is not available on this site.

11/22/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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