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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080445
Company: WEST-WARD PHARMS INT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Prescription AP No No
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription AP No No
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE;INJECTION Prescription AP No No
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription AP 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
01/22/1975 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2023 SUPPL-51 Labeling-Package Insert

Label is not available on this site.
08/10/2023 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
04/28/2005 SUPPL-38 Labeling

Label is not available on this site.
04/10/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.
04/30/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
09/22/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
03/13/1992 SUPPL-21 Labeling

Label is not available on this site.
10/16/1991 SUPPL-20 Labeling

Label is not available on this site.
04/03/1991 SUPPL-19 Labeling

Label is not available on this site.
12/18/1990 SUPPL-18 Labeling

Label is not available on this site.
09/19/1989 SUPPL-17 Labeling

Label is not available on this site.
07/20/1989 SUPPL-16 Labeling

Label is not available on this site.
12/28/1988 SUPPL-14 Labeling

Label is not available on this site.
11/03/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
03/08/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

MEPERIDINE HYDROCHLORIDE

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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