Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204147
Company: EMCURE PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription AP No 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
10/15/2013 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
09/09/2019 SUPPL-21 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/23/2017 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

PROCHLORPERAZINE EDISYLATE

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 040540 ATHENEX INC
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204147 EMCURE PHARMS LTD
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 210710 MYLAN LABS LTD
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204860 NEXUS PHARMS
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 089903 WEST-WARD PHARMS INT

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