ICATIBANT ACETATE
FRESENIUS KABI USA · ICATIBANT ACETATE
Open FDA's page for this record- Application number
- ANDA208317
- Sponsor name
- FRESENIUS KABI USA
- Submissions
- Submission type
- SUPPL
- Submission number
- 3
- Submission status
- AP
- Submission status date
- 20250509
- Review priority
- STANDARD
- Submission class code
- LABELING
- Submission class code description
- Labeling
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20200618
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Submission type
- SUPPL
- Submission number
- 7
- Submission status
- AP
- Submission status date
- 20261023
- Review priority
- UNKNOWN
- Submission class code
- MANUF (CMC)
- Submission class code description
- Manufacturing (CMC)
- Products
- Product number
- 001
- Reference drug
- No
- Brand name
- ICATIBANT ACETATE
- Reference standard
- No
- Dosage form
- INJECTABLE
- Route
- SUBCUTANEOUS
- Marketing status
- Prescription
- Te code
- AP
- Active ingredients
- Name
- ICATIBANT ACETATE
- Strength
- EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
- Harmonized identifiers (openFDA)
- Application number
- ANDA208317
- Brand name
- ICATIBANT
- Generic name
- ICATIBANT
- Manufacturer name
- Fresenius Kabi USA, LLC
- Product NDC
- 63323-574
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- ICATIBANT ACETATE
- RxCUI
- 1148141
- SPL ID
- d1c9afa7-c4ac-4739-85f1-2ae82440210c
- SPL set ID
- 52c12c15-c00b-4efc-952d-1425c907706a
- Package NDC
- 63323-574-01, 63323-574-86, 63323-574-93
- UNII
- 325O8467XK