Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203732
Company: PAR STERILE PRODUCTS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE;INJECTION Prescription AO 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
07/03/2014 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
02/23/2017 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
11/18/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

FLUPHENAZINE DECANOATE

INJECTABLE;INJECTION; 25MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE;INJECTION Prescription No AO 207739 AUROBINDO PHARMA LTD
FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE;INJECTION Prescription No AO 071413 FRESENIUS KABI USA
FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE;INJECTION Prescription No AO 075918 MYLAN LABS LTD
FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE;INJECTION Prescription No AO 203732 PAR STERILE PRODUCTS
FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE;INJECTION Prescription No AO 074531 WEST-WARD PHARMS INT

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