Report / Drug application metadata
ACTHAR GEL
The application NDA008372 lists 4 product formulations. Its sponsor is MALLINCKRODT IRELAND. The product details below come from the application record, not a prescribing guide.
Which products are in this application?
ACTHAR GEL
- Active ingredients
- CORTICOTROPIN 40 UNITS/ML
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Discontinued
- Product number
- 006
ACTHAR GEL (AUTOINJECTOR)
- Active ingredients
- CORTICOTROPIN 80 UNITS/ML
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Product number
- 004
ACTHAR GEL (AUTOINJECTOR)
- Active ingredients
- CORTICOTROPIN 40 UNITS/0.5ML
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Product number
- 003
ACTHAR GEL
- Active ingredients
- CORTICOTROPIN 80 UNITS/ML
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Product number
- 008
How should this information be used?
An application can contain several product versions and a history of submissions. The details shown here do not establish current availability in a particular country or pharmacy, and a listed strength is not a recommended dose. Check the current approved product label for indications, contraindications, warnings and dosing.
This page does not infer a medicine's treatment uses from its name or regulatory status. Application metadata is evidence about the listed product, not evidence that it is suitable for an individual patient.
- Kind
- Drug application metadata
- Identifier
- NDA008372
- Sponsor
- MALLINCKRODT IRELAND