Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013263
Company: WAYLIS THERAP
Company: WAYLIS THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALIUM | DIAZEPAM | 2MG | TABLET;ORAL | Prescription | AB | Yes | No |
| VALIUM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| VALIUM | DIAZEPAM | 10MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 11/15/1963 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 03/19/2024 | SUPPL-101 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/11/2023 | SUPPL-100 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013263Orig1s100ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013263Orig1s100ltr.pdf | |
| 03/14/2023 | SUPPL-98 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013263Orig1s098ltr.pdf | |
| 01/13/2023 | SUPPL-97 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013263Orig1s097ltr.pdf | |
| 02/05/2021 | SUPPL-96 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013263s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/013263Orig1s096ltr.pdf | |
| 12/16/2016 | SUPPL-94 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/013263Orig1s094ltr.pdf | |
| 07/30/2015 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/2013 | SUPPL-92 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/013263Orig1s092ltr.pdf | |
| 04/19/2013 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2002 | SUPPL-86 | Manufacturing (CMC)-Control |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13263s86ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S086_VALIUM_AP.pdf |
| 11/08/2001 | SUPPL-85 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/25/2001 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/2008 | SUPPL-83 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf | |
| 05/09/2001 | SUPPL-82 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13263s82ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013263_S082_Valium_APPROVAL PACKAGE.pdf |
| 08/30/2000 | SUPPL-81 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/016087_S081_VALIUM_AP.pdf |
| 05/12/2008 | SUPPL-80 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf |
| 09/04/1998 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/1997 | SUPPL-78 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/05/1997 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-76 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-75 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S075_VALIUM_AP.pdf |
| 10/26/1989 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1988 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-72 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S072_VALIUM_AP.pdf |
| 01/20/1988 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1986 | SUPPL-70 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1984 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/1984 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 01/20/1983 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/20/1983 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-64 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/30/1982 | SUPPL-63 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/18/1982 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 10/18/1982 | SUPPL-61 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/18/1982 | SUPPL-60 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/18/1982 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/11/1982 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1982 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1983 | SUPPL-55 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/26/1981 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 07/17/1981 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1980 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1980 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/19/1980 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 01/09/1981 | SUPPL-48 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/20/1979 | SUPPL-47 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/02/1979 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 04/04/1979 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/26/1980 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1978 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 09/21/1977 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 12/14/1976 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 10/27/1976 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 08/27/1976 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/25/1975 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1975 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1975 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1974 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/11/2023 | SUPPL-100 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s100lbl.pdf | |
| 03/14/2023 | SUPPL-98 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s098lbl.pdf | |
| 03/14/2023 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s098lbl.pdf | |
| 01/13/2023 | SUPPL-97 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263s097lbl.pdf | |
| 02/05/2021 | SUPPL-96 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013263s096lbl.pdf | |
| 12/16/2016 | SUPPL-94 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf | |
| 12/16/2016 | SUPPL-94 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf | |
| 10/22/2013 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf | |
| 05/12/2008 | SUPPL-83 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf |
VALIUM
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 | 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 | 077749 | STRIDES PHARMA |
| VALIUM | DIAZEPAM | 5MG | TABLET;ORAL | Prescription | Yes | AB | 013263 | WAYLIS THERAP |
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 |