Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074531
Company: HIKMA
Company: HIKMA
| 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-Package Insert, Labeling-Container/Carton Labels |
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 | 203732 | ENDO OPERATIONS |
| 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 |