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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 008372

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ACTHAR GEL (CORTICOTROPIN)
80 UNITS/ML
Marketing Status: Prescription
Active Ingredient: CORTICOTROPIN
Proprietary Name: ACTHAR GEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N008372
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MALLINCKRODT PHARMACEUTICALS IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTHAR GEL (AUTOINJECTOR) (CORTICOTROPIN)
40 UNITS/0.5ML
Marketing Status: Prescription
Active Ingredient: CORTICOTROPIN
Proprietary Name: ACTHAR GEL (AUTOINJECTOR)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40 UNITS/0.5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N008372
Product Number: 003
Approval Date: Feb 29, 2024
Applicant Holder Full Name: MALLINCKRODT PHARMACEUTICALS IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTHAR GEL (AUTOINJECTOR) (CORTICOTROPIN)
80 UNITS/ML
Marketing Status: Prescription
Active Ingredient: CORTICOTROPIN
Proprietary Name: ACTHAR GEL (AUTOINJECTOR)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N008372
Product Number: 004
Approval Date: Feb 29, 2024
Applicant Holder Full Name: MALLINCKRODT PHARMACEUTICALS IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTHAR GEL (CORTICOTROPIN)
40 UNITS/ML
Marketing Status: Discontinued
Active Ingredient: CORTICOTROPIN
Proprietary Name: ACTHAR GEL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N008372
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MALLINCKRODT PHARMACEUTICALS IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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