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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005010
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DEMEROL MEPERIDINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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DEMEROL MEPERIDINE HYDROCHLORIDE 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP;ORAL Discontinued None No No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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/15/2023 SUPPL-60 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005010s060lbl.pdf
12/15/2023 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005010s060lbl.pdf
03/04/2021 SUPPL-59 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf
03/04/2021 SUPPL-59 Labeling-Package Insert 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
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