Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040164
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKPENTOLATE CYCLOPENTOLATE HYDROCHLORIDE 1% 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-8 Labeling-Container/Carton Labels

Label is not available on this site.

07/25/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/09/2001 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

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

Label is not available on this site.

07/11/2001 SUPPL-2 Manufacturing (CMC)-Facility

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; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AKPENTOLATE CYCLOPENTOLATE HYDROCHLORIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040164 AKORN
CYCLOGYL CYCLOPENTOLATE HYDROCHLORIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 084110 NOVARTIS PHARMS CORP
PENTOLAIR CYCLOPENTOLATE HYDROCHLORIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040075 BAUSCH AND LOMB

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