Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021764
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QOLIANA | BRIMONIDINE TARTRATE | 0.15% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
05/22/2006 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021764lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021764s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021764s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/19/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/10/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/25/2014 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/27/2012 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021764s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021764s005ltr.pdf | |
08/03/2010 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021764s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021764s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/27/2012 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021764s005lbl.pdf | |
08/03/2010 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021764s002lbl.pdf | |
05/22/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021764lbl.pdf |
QOLIANA
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 | ABBVIE |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.15% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 215225 | ALEMBIC |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.15% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078479 | APOTEX |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.15% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 216772 | UPSHER SMITH LABS |
QOLIANA | BRIMONIDINE TARTRATE | 0.15% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 021764 | SANDOZ |