Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214361
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
10/15/2020 | 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 | 215829 | ACIC PHARMS |
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 | 214361 | GLAND PHARMA LTD |
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 |