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
ALREX از شرکت BAUSCH AND LOMB
New Drug Application (NDA): 020803
Company: BAUSCH AND LOMB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALREX | LOTEPREDNOL ETABONATE | 0.2% | SUSPENSION/DROPS;OPHTHALMIC | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 03/09/1998 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20803lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/16/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1999 | 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 |
|---|---|---|---|---|---|
| 03/09/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20803lbl.pdf |
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