Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074531
Company: WEST-WARD PHARMS INT
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
08/30/1996 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-15 Labeling-Package Insert

Label is not available on this site.

10/17/2013 SUPPL-13 Labeling-Container/Carton Labels, 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.

05/22/2009 SUPPL-8 Labeling

Label is not available on this site.

10/30/2008 SUPPL-7 Labeling

Label is not available on this site.

08/19/2008 SUPPL-6 Labeling

Label is not available on this site.

04/03/2001 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074531Orig1s001.pdf

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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