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
ALOCRIL از شرکت ALLERGAN
New Drug Application (NDA): 021009
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALOCRIL | NEDOCROMIL SODIUM | 2% | 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 |
|---|---|---|---|---|---|---|---|
| 12/08/1999 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/13/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/2008 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021009s010ltr.pdf |
||
| 10/18/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf |
|
| 10/18/2004 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf |
|
| 08/21/2007 | SUPPL-4 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003, 021009s004ltr.pdf |
||
| 08/21/2007 | SUPPL-3 | Manufacturing (CMC)-Packaging |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003, 021009s004ltr.pdf |
||
| 03/08/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21009s2ltr.pdf |
|
| 07/18/2000 | 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 |
|---|---|---|---|---|---|
| 07/07/2008 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021009s010lbl.pdf | |
| 08/21/2007 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf | |
| 08/21/2007 | SUPPL-3 |
Manufacturing (CMC)-Packaging |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf | |
| 12/08/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf |
ALOCRIL
SOLUTION/DROPS;OPHTHALMIC; 2%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALOCRIL | NEDOCROMIL SODIUM | 2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 021009 | ALLERGAN |
| NEDOCROMIL SODIUM | NEDOCROMIL SODIUM | 2% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090638 | AKORN |
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