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Drugs@FDA: FDA-Approved Drugs

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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
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-Package Insert, Labeling-Container/Carton Labels 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-Package Insert, Labeling-Container/Carton Labels 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.
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-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
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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