FdaApplication
ANDA 220243
Identifiers
- fda_app_no: ANDA220243
Properties
| Property | Value |
|---|---|
| applicant_name | CAPLIN STERILES LTD |
| application_type | ANDA |
| approval_date | 2025-10-22 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS |
2 products