Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071413
Company: FRESENIUS KABI USA
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 | EUGIA PHARMA |
| 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 | 215509 | GLAND PHARMA LTD |
| FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 074531 | HIKMA |
| FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 215365 | MSN |
| 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 |