Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203168
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROLENSA | BROMFENAC SODIUM | EQ 0.07% 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 |
---|---|---|---|---|---|---|---|
04/05/2013 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203168s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203168Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168_prolensa_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203168Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/02/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/05/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203168s000lbl.pdf |
PROLENSA
SOLUTION/DROPS;OPHTHALMIC; EQ 0.07% 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 0.07% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 214340 | ALEMBIC |
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.07% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 210962 | AMNEAL |
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.07% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 207334 | APOTEX |
BROMFENAC SODIUM | BROMFENAC SODIUM | EQ 0.07% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 206027 | LUPIN LTD |
PROLENSA | BROMFENAC SODIUM | EQ 0.07% ACID | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 203168 | BAUSCH AND LOMB |