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
ACTIVELLA از شرکت AMNEAL
New Drug Application (NDA): 020907
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription |
AB |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 11/18/1998 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20907lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/06/2020 | SUPPL-25 | Manufacturing (CMC)-Packaging |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020907s025lbl.pdf |
||
| 08/10/2021 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020907Orig1s020,s022ltr.pdf |
|
| 08/10/2021 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020907s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020907Orig1s020,s022ltr.pdf |
||
| 11/01/2017 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020907s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020907s019ltr.pdf |
||
| 05/27/2016 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/2013 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020907Orig1s013ltr.pdf |
||
| 12/28/2006 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf |
||
| 12/28/2006 | SUPPL-9 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf |
||
| 07/26/2004 | SUPPL-7 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020907_S007.pdf |
||
| 09/13/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020907_S006.pdf |
|
| 06/30/2005 | SUPPL-5 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020907s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020907s005ltr.pdf |
||
| 11/14/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S004.pdf |
|
| 04/11/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S003.pdf |
|
| 02/10/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S002.pdf |
|
| 11/03/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020907_S001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/10/2021 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020907s020s022lbl.pdf | |
| 04/06/2020 | SUPPL-25 |
Manufacturing (CMC)-Packaging |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020907s025lbl.pdf | |
| 11/01/2017 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020907s019lbl.pdf | |
| 10/08/2013 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf | |
| 12/28/2006 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf | |
| 12/28/2006 | SUPPL-9 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf | |
| 06/30/2005 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020907s005lbl.pdf | |
| 11/18/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20907lbl.pdf |
ACTIVELLA
TABLET;ORAL; 1MG;0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | Yes | AB | 020907 | AMNEAL |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 079193 | BARR |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 078324 | BRECKENRIDGE PHARM |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 207261 | MYLAN LABS LTD |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 210612 | NOVAST LABS |
TABLET;ORAL; 0.5MG;0.1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | Yes | AB | 020907 | AMNEAL |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 078324 | BRECKENRIDGE PHARM |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 207261 | MYLAN LABS LTD |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 210612 | NOVAST LABS |
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