Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008708
Company: CONCORDIA
Company: CONCORDIA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIBENZYLINE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/03/2008 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008708s025lbl.pdf |