← FDA Drug Approvals (Drugs@FDA)
IRINOTECAN HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: INTAS PHARMS USA · Approved 2017-08-31
Drug application
- FDA Application #
ANDA203054- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IRINOTECAN HYDROCHLORIDE
- Generic name
- Irinotecan Hydrochloride
- Active ingredients
- IRINOTECAN HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- INTAS PHARMS USA
- First approval
- 2017-08-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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