Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215365
Company: MSN
Company: MSN
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 |
---|---|---|---|---|---|---|---|
11/02/2023 | ORIG-1 | Approval | STANDARD |
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 | 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 |