Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206911
Company: SUN PHARM
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 |