Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040540
Company: ATHENEX INC
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 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
05/28/2004 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
03/11/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/17/2009 SUPPL-8 Labeling

Label is not available on this site.

03/12/2009 SUPPL-7 Labeling

Label is not available on this site.

09/03/2008 SUPPL-5 Labeling

Label is not available on this site.

09/25/2007 SUPPL-3 Labeling

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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