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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040165
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKPENTOLATE CYCLOPENTOLATE HYDROCHLORIDE 2% SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
01/13/1997 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
07/19/2017 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

07/25/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/09/2001 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

10/09/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1999 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

AKPENTOLATE

SOLUTION/DROPS;OPHTHALMIC; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AKPENTOLATE CYCLOPENTOLATE HYDROCHLORIDE 2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040165 AKORN
CYCLOGYL CYCLOPENTOLATE HYDROCHLORIDE 2% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 084108 ALCON LABS INC
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