Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085555
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AK-PENTOLATE CYCLOPENTOLATE HYDROCHLORIDE 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
04/10/1979 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
03/18/1991 SUPPL-5 Labeling

Label is not available on this site.

02/13/1991 SUPPL-4 Labeling

Label is not available on this site.

04/25/1989 SUPPL-3 Labeling

Label is not available on this site.

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