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
ACTHAR GEL از شرکت MALLINCKRODT ARD
New Drug Application (NDA): 008372
Company: MALLINCKRODT ARD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTHAR GEL | CORTICOTROPIN | 40 UNITS/ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| ACTHAR GEL | CORTICOTROPIN | 80 UNITS/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/1952 | 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 |
|---|---|---|---|---|---|
| 10/29/2021 | SUPPL-71 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/008372Orig1s071ltr.pdf |
||
| 03/02/2021 | SUPPL-68 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/008372Orig1s068ltr.pdf |
||
| 03/26/2019 | SUPPL-61 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008372s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/008372Orig1s061ltr.pdf |
||
| 04/26/2018 | SUPPL-57 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008372Orig1s057Ltr.pdf |
||
| 07/31/2017 | SUPPL-55 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/19/2016 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/2016 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/2016 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/2016 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/2012 | SUPPL-45 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008372s045ltr.pdf |
|
| 03/24/2015 | SUPPL-44 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008372s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008372Orig1s044ltr.pdf |
||
| 11/06/2002 | SUPPL-35 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/15/1999 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1998 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/05/1994 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/26/1993 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/22/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/25/1985 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1985 | SUPPL-27 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/29/1984 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/24/1983 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/26/1981 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 06/26/1979 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/26/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/26/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/26/1979 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/14/1978 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/05/1977 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/01/1977 | SUPPL-15 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/29/2021 | SUPPL-71 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s071lbl.pdf | |
| 03/02/2021 | SUPPL-68 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s068lbl.pdf | |
| 03/26/2019 | SUPPL-61 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008372s061lbl.pdf | |
| 03/26/2019 | SUPPL-61 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008372s061lbl.pdf | |
| 04/26/2018 | SUPPL-57 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf | |
| 03/24/2015 | SUPPL-44 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008372s044lbl.pdf |
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