Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090260
Company: PHARM ASSOC
Company: PHARM ASSOC
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 |
---|---|---|---|---|---|---|---|
06/15/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/23/2010 | SUPPL-1 | Labeling-Container/Carton Labels |
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 | 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 |