Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021398
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COMBIGAN | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | 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 |
---|---|---|---|---|---|---|---|
10/30/2007 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021398s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021398s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/15/2015 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021398s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021398Orig1s007ltr.pdf | |
10/11/2012 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021398Orig1s006ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/15/2015 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021398s007lbl.pdf | |
10/11/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf |
COMBIGAN
SOLUTION/DROPS;OPHTHALMIC; 0.2%;EQ 0.5% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 215230 | ALEMBIC |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 091442 | APOTEX |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 201949 | FLORIDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 214987 | GLENMARK PHARMS LTD |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 091087 | SANDOZ |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 091086 | SENTISS |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 216114 | SOMERSET |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 215598 | UPSHER SMITH LABS |
COMBIGAN | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | 0.2%;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 021398 | ABBVIE |