Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040578
Company: SCINOPHARM TAIWAN
Company: SCINOPHARM TAIWAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040578ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/10/2010 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/21/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |