Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074496
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
LORAZEPAM | LORAZEPAM | 4MG/ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
09/28/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74496_Lorazepam_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74496ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074496_lorazepam_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/08/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/30/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/28/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74496_Lorazepam_Prntlbl.pdf |