FdaApplication
ANDA 211078
Identifiers
- fda_app_no: ANDA211078
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2018-07-19 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS |
2 products