FdaApplication
NDA 208313
Identifiers
- fda_app_no: NDA208313
Properties
| Property | Value |
|---|---|
| applicant_name | SUN PHARMACEUTICAL INDUSTRIES LTD |
| application_type | NDA |
| approval_date | 2018-07-16 |
Products (10)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
| INFUGEM | GEMCITABINE HYDROCHLORIDE | EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS |
10 products