Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213352
Company: NEPHRON
Company: NEPHRON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
03/17/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
VERAPAMIL HYDROCHLORIDE
SOLUTION;INTRAVENOUS; 10MG/4ML (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 | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210994 | AMNEAL |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213232 | CAPLIN |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 070737 | HOSPIRA |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211370 | MICRO LABS |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213352 | NEPHRON |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211035 | SOMERSET |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211015 | SOMERSET THERAPS LLC |
SOLUTION;INTRAVENOUS; 5MG/2ML (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 | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210994 | AMNEAL |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213232 | CAPLIN |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 018925 | EXELA PHARMA |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 070737 | HOSPIRA |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 070738 | HOSPIRA |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 075136 | HOSPIRA |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211370 | MICRO LABS |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213352 | NEPHRON |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211035 | SOMERSET |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 211015 | SOMERSET THERAPS LLC |