Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005010
Company: US PHARM HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMEROL MEPERIDINE HYDROCHLORIDE 50MG 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DEMEROL MEPERIDINE HYDROCHLORIDE 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None No No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
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
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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