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 P از شرکت ALLERGAN
New Drug Application (NDA): 021262
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPHAGAN P | 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 |
|---|---|---|---|---|---|---|---|
| 03/16/2001 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/19/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2010 | SUPPL-20 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021262s020,021770s004ltr.pdf |
||
| 05/22/2006 | SUPPL-18 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021262s018LTR.pdf |
||
| 02/10/2004 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf |
|
| 02/10/2004 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf |
|
| 04/12/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/2001 | SUPPL-6 | 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-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/13/2010 | SUPPL-20 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf | |
| 05/22/2006 | SUPPL-18 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf | |
| 12/20/2001 | SUPPL-6 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf | |
| 03/16/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf |
ALPHAGAN P
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 | ALLERGAN |
| QOLIANA | BRIMONIDINE TARTRATE | 0.15% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 021764 | SANDOZ INC |
نظرات کاربران