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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080455
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
04/26/1972 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
11/10/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
01/17/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
07/30/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
03/04/1992 SUPPL-25 Labeling

Label is not available on this site.
07/30/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
01/22/1990 SUPPL-23 Labeling

Label is not available on this site.
05/23/1988 SUPPL-21 Labeling

Label is not available on this site.
03/27/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
12/02/1983 SUPPL-14 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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