Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040235
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENTOLAMINE MESYLATE | PHENTOLAMINE MESYLATE | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/11/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40235ap.pdf |
PHENTOLAMINE MESYLATE
INJECTABLE;INJECTION; 5MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PHENTOLAMINE MESYLATE | PHENTOLAMINE MESYLATE | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040235 | HIKMA |
PHENTOLAMINE MESYLATE | PHENTOLAMINE MESYLATE | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207686 | PRECISION DOSE INC |