Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074515
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLOL MALEATE TIMOLOL MALEATE EQ 0.25% BASE 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
03/25/1997 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
11/22/1999 SUPPL-5 Labeling

Label is not available on this site.

06/07/1999 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/06/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/28/1999 SUPPL-2 Labeling

Label is not available on this site.

02/12/1998 SUPPL-1 Labeling

Label is not available on this site.

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