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
ALORA از شرکت ALLERGAN
New Drug Application (NDA): 020655
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALORA | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription |
BX |
No | No |
| ALORA | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription |
BX |
No | No |
| ALORA | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription |
BX |
No | No |
| ALORA | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription |
BX |
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 |
|---|---|---|---|---|---|---|---|
| 12/20/1996 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2017 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf |
||
| 03/30/2020 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020655Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020655Orig1s019ltr.pdf |
||
| 08/30/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/2005 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020655s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020655s011ltr.pdf |
||
| 04/05/2002 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20655s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-665s008_Alora.cfm |
||
| 10/02/2001 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/2003 | SUPPL-6 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20655slr006ltr.pdf |
||
| 04/14/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/04/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/24/1998 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/22/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1997 | 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 |
|---|---|---|---|---|---|
| 03/30/2020 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020655Orig1s019lbl.pdf | |
| 11/01/2017 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf | |
| 05/19/2005 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020655s011lbl.pdf | |
| 11/18/2003 | SUPPL-6 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf | |
| 04/05/2002 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf |
ALORA
There are no Therapeutic Equivalents.
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