اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ALPHAGAN از شرکت ALLERGAN
New Drug Application (NDA): 020613
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| ALPHAGAN | BRIMONIDINE TARTRATE | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued |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 |
|
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 |
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 |
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 |
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