← FDA DRUG APPROVALS

FDA NDA · NDA008372

ACTHAR

repository corticotropin

Sponsor: MALLINCKRODT IRELAND

APPLICATION
NDA008372
TYPE
NDA
ORIGINAL APPROVAL
1952-04-29
LATEST ACTION
2024-02-29
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

ACTHAR GELDiscontinued
CORTICOTROPIN 40 UNITS/ML · INJECTABLE · INJECTION
ACTHAR GEL (AUTOINJECTOR) · ReferencePrescription
CORTICOTROPIN 80 UNITS/ML · INJECTABLE · INJECTION
ACTHAR GEL (AUTOINJECTOR) · ReferencePrescription
CORTICOTROPIN 40 UNITS/0.5ML · INJECTABLE · INJECTION
ACTHAR GEL · ReferencePrescription
CORTICOTROPIN 80 UNITS/ML · INJECTABLE · INJECTION

Approval history

2024-02-29Labeling · Supplement 74 · standard — Label ↗AP
2021-10-29Labeling · Supplement 71 · standard — Label ↗AP
2021-03-02Labeling · Supplement 68 · standard — Letter ↗AP
2019-03-26Labeling · Supplement 61 · standard — Label ↗AP
2018-04-26Labeling · Supplement 57 · standard — Label ↗AP
2017-07-31Labeling · Supplement 55 · standardAP
2016-04-19Manufacturing (CMC) · Supplement 51 · standardAP
2016-03-14Manufacturing (CMC) · Supplement 50 · standardAP
2016-03-11Manufacturing (CMC) · Supplement 49 · standardAP
2016-03-04Manufacturing (CMC) · Supplement 48 · standardAP
2015-03-24Labeling · Supplement 44 · standard — Letter ↗AP
2014-01-17Manufacturing (CMC) · Supplement 47 · standardAP
2012-07-05REMS · Supplement 45 — Review ↗AP
2002-11-06Manufacturing (CMC) · Supplement 35 · standardAP
1999-07-15Manufacturing (CMC) · Supplement 34 · standardAP
1998-12-15Manufacturing (CMC) · Supplement 33 · standardAP
1994-04-05Manufacturing (CMC) · Supplement 31 · standardAP
1993-03-26Manufacturing (CMC) · Supplement 30 · standardAP
1992-04-22Labeling · Supplement 29AP
1985-03-25Manufacturing (CMC) · Supplement 28 · standardAP
1985-01-15Manufacturing (CMC) · Supplement 27 · standardAP
1984-08-29Manufacturing (CMC) · Supplement 26 · standardAP
1983-08-24Labeling · Supplement 25AP
1981-03-26Labeling · Supplement 24AP
1979-06-26Labeling · Supplement 21AP
1979-06-26Labeling · Supplement 18AP
1979-06-26Manufacturing (CMC) · Supplement 22 · standardAP
1979-06-26Labeling · Supplement 20AP
1978-03-14Labeling · Supplement 17AP
1977-10-05Labeling · Supplement 16AP
1977-06-01Labeling · Supplement 15AP
1952-04-29Type 5 - New Formulation or New Manufacturer · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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