Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200169
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORAZEPAM | LORAZEPAM | 2MG/ML | CONCENTRATE;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
01/30/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
LORAZEPAM
CONCENTRATE;ORAL; 2MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LORAZEPAM | LORAZEPAM | 2MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 091383 | AMNEAL PHARMS |
LORAZEPAM | LORAZEPAM | 2MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 200169 | HIKMA |
LORAZEPAM | LORAZEPAM | 2MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 091407 | LUPIN LTD |
LORAZEPAM | LORAZEPAM | 2MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 090260 | PHARM ASSOC |
LORAZEPAM INTENSOL | LORAZEPAM | 2MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 072755 | HIKMA |