← FDA Drug Approvals (Drugs@FDA)
GEMCITABINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SHILPA · Approved 2019-10-04
Drug application
- FDA Application #
ANDA210991- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GEMCITABINE HYDROCHLORIDE
- Generic name
- GEMCITABINE HYDROCHLORIDE
- Active ingredients
- GEMCITABINE HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- SHILPA
- Manufacturer
- Armas Pharmaceuticals Inc.
- First approval
- 2019-10-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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