Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062523
Company: ALCON PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE 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
11/25/1985 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-21 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

02/02/1999 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/04/1996 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/16/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/27/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/18/1994 SUPPL-12 Labeling

Label is not available on this site.

01/27/1994 SUPPL-11 Labeling

Label is not available on this site.

10/16/1991 SUPPL-10 Labeling

Label is not available on this site.

11/22/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/11/1992 SUPPL-8 Labeling

Label is not available on this site.

02/11/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/29/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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