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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214107
Company: GLAND PHARMA 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 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
09/22/2021 ORIG-1 Approval STANDARD

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 214379 CAPLIN
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 213873 EUGIA PHARMA
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 214107 GLAND PHARMA LTD
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 089903 HIKMA
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 213626 VIWIT PHARM
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