← FDA Drug Approvals (Drugs@FDA)
INFUGEM
NDA · New Drug Application · Sponsor: SUN PHARM · Approved 2018-07-16
Drug application
- FDA Application #
NDA208313
- Application type
- New Drug Application
- Brand name
- INFUGEM
- Generic name
- Gemcitabine Hydrochloride
- Active ingredients
- GEMCITABINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing status
- Discontinued
- Sponsor
- SUN PHARM
- First approval
- 2018-07-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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