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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021171
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMEROL MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DEMEROL MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DEMEROL MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DEMEROL MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription AP 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
11/10/1942 ORIG-1 Approval UNKNOWN

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-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021171s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021171Orig1s053ltr.pdf
10/21/2022 SUPPL-51 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021171Orig1s051lbl.pdf
10/07/2019 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021171s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021171Orig1s032ltr.pdf
12/16/2016 SUPPL-25 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021171s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021171Orig1s024,s025ltr.pdf
12/16/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021171s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021171Orig1s024,s025ltr.pdf
06/24/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
04/19/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
08/24/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
01/31/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
12/09/1999 SUPPL-2 Labeling

Label is not available on this site.
11/17/1998 SUPPL-1 Manufacturing (CMC)-Packaging

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-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021171s053lbl.pdf
10/21/2022 SUPPL-51 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021171Orig1s051lbl.pdf
10/21/2022 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021171Orig1s051lbl.pdf
10/07/2019 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021171s032lbl.pdf
12/16/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021171s024s025lbl.pdf
12/16/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021171s024s025lbl.pdf
12/16/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021171s024s025lbl.pdf

DEMEROL

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMEROL MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Prescription Yes AP 021171 HOSPIRA
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 080445 WEST-WARD PHARMS INT
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Prescription No AP 080455 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMEROL MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 021171 HOSPIRA
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 080445 WEST-WARD PHARMS INT
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 080455 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 75MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMEROL MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE;INJECTION Prescription Yes AP 021171 HOSPIRA
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE;INJECTION Prescription No AP 080445 WEST-WARD PHARMS INT
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE;INJECTION Prescription No AP 080455 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMEROL MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription Yes AP 021171 HOSPIRA
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription No AP 080445 WEST-WARD PHARMS INT
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription No AP 080455 WEST-WARD PHARMS INT
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