Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005010
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEMEROL | MEPERIDINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| DEMEROL | MEPERIDINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DEMEROL | MEPERIDINE HYDROCHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DEMEROL | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | Yes | No |
| DEMEROL | MEPERIDINE HYDROCHLORIDE | 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | No | No |
| DEMEROL | MEPERIDINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DEMEROL | MEPERIDINE HYDROCHLORIDE | 75MG/ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 11/10/1942 | 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-60 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005010s060lbl.pdf | |
| 03/04/2021 | SUPPL-59 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/005010Orig1s059ltr.pdf | |
| 10/07/2019 | SUPPL-58 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005010s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/005010Orig1s058ltr.pdf | |
| 09/18/2018 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/005010Orig1s056s057ltr.pdf | |
| 09/18/2018 | SUPPL-56 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/005010Orig1s056s057ltr.pdf | |
| 08/16/2017 | SUPPL-55 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005010s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005010Orig1s055ltr.pdf | |
| 12/16/2016 | SUPPL-54 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/005010s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/005010Orig1s054ltr.pdf | |
| 10/31/2011 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005010s051ltr.pdf | |
| 04/11/2011 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005010s050ltr.pdf | |
| 03/05/2009 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005010s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005010s049ltr.pdf | |
| 05/15/2003 | SUPPL-48 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/05010slr048ltr.pdf |
| 02/26/2003 | SUPPL-47 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/05010slr047ltr.pdf |
| 10/17/2000 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1995 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1995 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/16/1995 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1995 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/10/1992 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1992 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/12/1991 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1990 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1990 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1989 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1989 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1989 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/24/1997 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/06/1988 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/18/1986 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/12/1986 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1985 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1985 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1984 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1983 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1983 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/28/1983 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1983 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1983 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/28/1983 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/07/1982 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/21/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/27/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/02/1977 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1978 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1976 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/04/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/18/1974 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005010s060lbl.pdf | |
| 12/15/2023 | SUPPL-60 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005010s060lbl.pdf | |
| 03/04/2021 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf | |
| 03/04/2021 | SUPPL-59 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf | |
| 10/07/2019 | SUPPL-58 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005010s058lbl.pdf | |
| 10/07/2019 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005010s058lbl.pdf | |
| 09/18/2018 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf | |
| 09/18/2018 | SUPPL-56 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf | |
| 08/16/2017 | SUPPL-55 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005010s055lbl.pdf | |
| 08/16/2017 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005010s055lbl.pdf | |
| 12/16/2016 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/005010s054lbl.pdf | |
| 12/16/2016 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/005010s054lbl.pdf | |
| 12/16/2016 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/005010s054lbl.pdf | |
| 10/31/2011 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s051lbl.pdf | |
| 04/11/2011 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s050lbl.pdf | |
| 03/05/2009 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005010s049lbl.pdf |