Drugs@FDA: FDA Approved Drug Products

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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
H.P. ACTHAR GEL CORTICOTROPIN 40 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
H.P. 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
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)

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 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
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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