Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071135
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 02/03/1987 | 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 |
|---|---|---|---|---|---|
| 07/02/1993 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 08/02/2021 | SUPPL-38 | Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2021 | SUPPL-35 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/06/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/21/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/11/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
DIAZEPAM
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 217843 | AUROBINDO PHARMA LTD |
| DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 071135 | DR REDDYS LABS SA |
| DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 071321 | IVAX SUB TEVA PHARMS |
| DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 070325 | MYLAN |
| DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 070464 | NUVO PHARM |
| VALIUM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | Yes | AB | 013263 | WAYLIS THERAP |