Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010656
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOROPRYL ISOFLUROPHATE 0.025% OINTMENT;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
04/02/1957 ORIG-1 Approval Type 3 - New Dosage Form 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
07/10/1995 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1993 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/28/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/19/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/04/1990 SUPPL-17 Labeling

Label is not available on this site.

12/04/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/30/1989 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/06/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/27/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/19/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1987 SUPPL-10 Labeling

Label is not available on this site.

01/09/1978 SUPPL-9 Labeling

Label is not available on this site.

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