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-D 24 HOUR ALLERGY AND CONGESTION از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 021704
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 180MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter |
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 |
|---|---|---|---|---|---|---|---|
| 10/19/2004 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21704lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/2016 | SUPPL-18 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020786Orig1s035,021704Orig1s018ltr.pdf |
||
| 06/08/2015 | SUPPL-17 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020786Orig1s033,021704Orig1s017ltr.pdf |
||
| 01/30/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/2012 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021704s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Orig1s013ltr.pdf |
||
| 08/23/2012 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Org1s011ltr.pdf |
|
| 02/03/2012 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010ltr.pdf |
|
| 01/24/2011 | SUPPL-8 | Efficacy-Rx To OTC Switch |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021704s008ltr.pdf |
||
| 04/14/2010 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021704s007ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/02/2016 | SUPPL-18 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf | |
| 06/08/2015 | SUPPL-17 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf | |
| 12/05/2012 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021704s013lbl.pdf | |
| 01/24/2011 | SUPPL-8 |
Efficacy-Rx To OTC Switch |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf | |
| 04/14/2010 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf | |
| 10/19/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21704lbl.pdf |
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 180MG;240MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 180MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 021704 | SANOFI AVENTIS US |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 180MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 079043 | DR REDDYS LABS LTD |
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