Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218218
Company: ASPIRO
Company: ASPIRO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/13/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
VERAPAMIL HYDROCHLORIDE
INJECTABLE;INJECTION; 2.5MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218218 | ASPIRO |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212965 | EUGIA PHARMA |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216471 | FRESENIUS KABI USA |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214361 | GLAND |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215829 | HERITAGE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214653 | MANKIND PHARMA |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 2.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214215 | ZYDUS PHARMS |