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
ALLEGRA از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 020625
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE;ORAL | Discontinued |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 07/25/1996 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20625lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/12/2003 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf |
||
| 07/11/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf |
|
| 05/12/2003 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf |
||
| 01/06/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020625_s009_ALLEGRA TABLETS.pdf |
|
| 01/21/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020625_s008_ALLEGRA_TABLETS.pdf |
|
| 12/22/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020625_s007_ALLEGRA TABLETS.pdf |
|
| 07/06/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020625_s006_ALLEGRA TABLETS.pdf |
|
| 01/29/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1996 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/12/2003 | SUPPL-12 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf | |
| 05/12/2003 | SUPPL-10 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf | |
| 07/25/1996 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20625lbl.pdf |
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