Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074725
Company: PHARM ASSOC
Company: PHARM ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG/ML | CONCENTRATE;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/1996 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074725ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/12/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |