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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089172
Company: ALCON PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROPICAMIDE TROPICAMIDE 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
12/28/1990 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
12/04/1996 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/16/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/30/1995 SUPPL-3 Labeling

Label is not available on this site.

08/21/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/08/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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