Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076439
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% 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
03/14/2006 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
10/10/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

BRIMONIDINE TARTRATE

SOLUTION/DROPS;OPHTHALMIC; 0.2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076439 AKORN
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076260 BAUSCH AND LOMB
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 091691 INDOCO REMEDIES
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076254 SANDOZ INC
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078075 SANDOZ INC
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 208992 SOMERSET THERAPS LLC

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