Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021770
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALPHAGAN P | BRIMONIDINE TARTRATE | 0.1% | 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 |
---|---|---|---|---|---|---|---|
08/19/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021770lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021770ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021770s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/05/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/22/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/12/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/05/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/13/2010 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021262s020,021770s004ltr.pdf | |
04/17/2006 | SUPPL-1 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021770s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/13/2010 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf | |
08/19/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021770lbl.pdf |
ALPHAGAN P
SOLUTION/DROPS;OPHTHALMIC; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALPHAGAN P | BRIMONIDINE TARTRATE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 021770 | ABBVIE |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 216909 | ALEMBIC |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 078480 | APOTEX |
BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 203172 | SANDOZ |