Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070464
Company: NUVO PHARM
Company: NUVO PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | None | No | No |
DIAZEPAM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | AB | No | No |
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 |
---|---|---|---|---|---|---|---|
02/25/1986 | 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 |
---|---|---|---|---|---|
11/22/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
06/16/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
06/30/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/12/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
07/21/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/21/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DIAZEPAM
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | No | AB | 217843 | AUROBINDO PHARMA LTD |
DIAZEPAM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | No | AB | 071136 | DR REDDYS LABS SA |
DIAZEPAM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | No | AB | 071322 | IVAX SUB TEVA PHARMS |
DIAZEPAM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | No | AB | 070325 | MYLAN |
DIAZEPAM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | No | AB | 070464 | NUVO PHARM |
DIAZEPAM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | No | AB | 077749 | STRIDES PHARMA |
VALIUM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | Yes | AB | 013263 | WAYLIS THERAP |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 217843 | AUROBINDO PHARMA LTD |
DIAZEPAM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 071134 | DR REDDYS LABS SA |
DIAZEPAM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 071307 | IVAX SUB TEVA PHARMS |
DIAZEPAM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 070325 | MYLAN |
DIAZEPAM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 070464 | NUVO PHARM |
DIAZEPAM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 077749 | STRIDES PHARMA |
VALIUM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | Yes | AB | 013263 | WAYLIS THERAP |
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 |
DIAZEPAM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | No | AB | 077749 | STRIDES PHARMA |
VALIUM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | Yes | AB | 013263 | WAYLIS THERAP |