Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011903
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLYSE CHYMOTRYPSIN 750 UNITS/VIAL FOR SOLUTION;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
07/08/1959 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/1992 SUPPL-14 Labeling

Label is not available on this site.

10/13/1989 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/03/1987 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1987 SUPPL-10 Labeling

Label is not available on this site.

12/20/1979 SUPPL-9 Labeling

Label is not available on this site.

05/08/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1979 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/17/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1974 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

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