Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040315
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROPICACYL TROPICAMIDE 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
09/29/2000 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
07/25/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

06/29/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

TROPICACYL

SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYDRIACYL TROPICAMIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 084306 NOVARTIS PHARMS CORP
TROPICACYL TROPICAMIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040315 AKORN
TROPICAMIDE TROPICAMIDE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040064 BAUSCH AND LOMB

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