Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072755
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORAZEPAM INTENSOL | LORAZEPAM | 2MG/ML | CONCENTRATE;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
06/28/1991 | 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 |
---|---|---|---|---|---|
04/06/2022 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
09/27/2017 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/29/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
09/14/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
04/20/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/14/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/28/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/08/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
LORAZEPAM INTENSOL
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 |