FdaApplication
ANDA 219115
Identifiers
- fda_app_no: ANDA219115
Properties
| Property | Value |
|---|---|
| applicant_name | ALEMBIC PHARMACEUTICALS LTD |
| application_type | ANDA |
| approval_date | 2025-11-12 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL |
| DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL |
2 products