FdaApplication
ANDA 216439
Identifiers
- fda_app_no: ANDA216439
Properties
| Property | Value |
|---|---|
| applicant_name | AMTA LABS LTD |
| application_type | ANDA |
| approval_date | 2023-03-07 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE;ORAL |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE;ORAL |
6 products