Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071413
Company: FRESENIUS KABI USA
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 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
07/14/1987 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-25 Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071413s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/071413s019ltr.pdf
07/22/2009 SUPPL-18 Labeling

Label is not available on this site.

12/05/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

02/28/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/28/1997 SUPPL-10 Labeling

Label is not available on this site.

02/28/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/03/2010 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071413s019lbl.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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