Drugs@FDA: FDA-Approved Drugs
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 |
ACTHAR GEL (AUTOINJECTOR) | CORTICOTROPIN | 40 UNITS/0.5ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
ACTHAR GEL (AUTOINJECTOR) | 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; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/29/2024 | SUPPL-74 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008372s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/008372Orig1s074ltr.pdf | |
10/29/2021 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008372s045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/008372Orig1s045.pdf |
03/24/2015 | SUPPL-44 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
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. |
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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 |
---|---|---|---|---|---|
02/29/2024 | SUPPL-74 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008372s074lbl.pdf | |
02/29/2024 | SUPPL-74 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008372s074lbl.pdf | |
02/29/2024 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008372s074lbl.pdf | |
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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008372s061lbl.pdf | |
03/26/2019 | SUPPL-61 | Labeling-Package Insert | 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 |