Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018140
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATIVAN | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| ATIVAN | LORAZEPAM | 4MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/25/1980 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018140s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018140Orig1s051ltr.pdf | |
| 02/05/2021 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/18140s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018140Orig1s046ltr.pdf | |
| 04/27/2017 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018140Orig1s041,018140Oirg1s042ltr.pdf | |
| 04/27/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018140Orig1s041,018140Oirg1s042ltr.pdf | |
| 05/27/2016 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018140s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018140Orig1s040ltr.pdf | |
| 10/02/2015 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/2016 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/2006 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018140s028ltr.pdf | |
| 12/12/2001 | SUPPL-27 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018140_S027_ATIVAN_INJECTION_AP.pdf |
| 09/26/2000 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/04/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1996 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1996 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/08/1995 | SUPPL-21 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/06/1995 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1993 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/29/1993 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/03/1993 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1992 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/02/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/19/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/13/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/13/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/24/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1983 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-3 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018140ap_s003.pdf |
| 02/02/1981 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/09/1980 | 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 |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018140s051lbl.pdf | |
| 02/05/2021 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/18140s046lbl.pdf | |
| 04/27/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf | |
| 04/27/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018140s041s042lbl.pdf | |
| 05/27/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018140s040lbl.pdf | |
| 11/29/2006 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf |
ATIVAN
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATIVAN | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018140 | HIKMA |
| LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074243 | HOSPIRA |
| LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074282 | HOSPIRA |
| LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076150 | INTL MEDICATION SYS |
| LORAZEPAM | LORAZEPAM | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075025 | RISING |
INJECTABLE;INJECTION; 4MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATIVAN | LORAZEPAM | 4MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018140 | HIKMA |
| LORAZEPAM | LORAZEPAM | 4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074243 | HOSPIRA |
| LORAZEPAM | LORAZEPAM | 4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074282 | HOSPIRA |