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Abbreviated New Drug Application (ANDA): 078479
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.15% 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
01/31/2022 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/078479Orig1s000ltr.pdf

BRIMONIDINE TARTRATE

SOLUTION/DROPS;OPHTHALMIC; 0.15%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPHAGAN P BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021262 ALLERGAN
BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078479 APOTEX
QOLIANA BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021764 SANDOZ INC
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