Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALPHAGAN | BRIMONIDINE TARTRATE | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/06/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020613Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/23/2016 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020613s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020613Orig1s031ltr.pdf | |
06/06/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/19/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
04/12/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/16/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/20/2001 | SUPPL-18 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine%20Tartrate%20Ophthalmic_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490s007_Alphagan.cfm | |
12/04/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/12/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/14/2001 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/09/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/09/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/13/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/02/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/26/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/13/1999 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
08/26/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/13/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
05/20/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/25/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/15/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/29/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/23/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020613s031lbl.pdf | |
12/20/2001 | SUPPL-18 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf |