Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072079
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 12/20/1988 | 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 |
|---|---|---|---|---|---|
| 04/25/2023 | SUPPL-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2019 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2015 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/22/1995 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/29/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/27/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/10/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DIAZEPAM
INJECTABLE;INJECTION; 10MG/2ML (5MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 218450 | ALEMBIC |
| DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210363 | BELOTECA |
| DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214745 | FRESENIUS KABI USA |
| DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 070313 | HIKMA |
| DIAZEPAM | DIAZEPAM | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 072079 | HOSPIRA |