Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080229
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPHCON FORTE NAPHAZOLINE HYDROCHLORIDE 0.1% 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
03/06/1974 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
04/28/2000 SUPPL-25 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/23/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/07/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-22 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/01/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/05/1995 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/04/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/02/1996 SUPPL-17 Labeling

Label is not available on this site.

04/06/1993 SUPPL-16 Labeling

Label is not available on this site.

06/04/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/04/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/27/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/06/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/26/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/26/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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