Composition
- Active ingredients
- GEMCITABINE 200MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- GEMCITABINE 2G · InjectableANDA090644-001 · Tentative approval
- GEMCITABINE 200MG · InjectableThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA078460.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Gemcitabine
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Eurohlth Intl
- Status
- Tentative approval
- FDA approval
- 19 Jan 2010
- Application
- ANDA078460-001