FdaApplication
NDA 209604
Identifiers
- fda_app_no: NDA209604
Properties
| Property | Value |
|---|---|
| applicant_name | ACCORD HEALTHCARE INC |
| application_type | NDA |
| approval_date | 2017-08-03 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1.5GM/15ML (100MG/ML) | SOLUTION;INTRAVENOUS |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 2GM/20ML (100MG/ML) | SOLUTION;INTRAVENOUS |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 1GM/10ML (100MG/ML) | SOLUTION;INTRAVENOUS |
| GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE | 200MG/2ML (100MG/ML) | SOLUTION;INTRAVENOUS |
4 products