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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206911
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BROMSITE BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS;OPHTHALMIC Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/08/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206911s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206911Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206911Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2023 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206911Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206911Orig1s008ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/09/2023 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206911Orig1s008lbl.pdf
04/08/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206911s000lbl.pdf

BROMSITE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.075% ACID
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BROMFENAC SODIUM BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS;OPHTHALMIC Prescription No AB 211239 LUPIN LTD
BROMSITE BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS;OPHTHALMIC Prescription Yes AB 206911 SUN PHARM
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