Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017914
Company: BAYER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIDESILON ACETIC ACID, GLACIAL; DESONIDE 2%;0.05% SOLUTION/DROPS;OTIC 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
02/21/1978 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
03/04/1991 SUPPL-8 Labeling

Label is not available on this site.

06/25/1997 SUPPL-5 Labeling

Label is not available on this site.

10/17/1988 SUPPL-4 Labeling

Label is not available on this site.

02/29/1980 SUPPL-2 Labeling

Label is not available on this site.

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