Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076835
Company: EPIC PHARMA
Company: EPIC PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLAVOXATE HYDROCHLORIDE | FLAVOXATE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
11/30/2005 | ORIG-1 | Approval |
Label is not available on this site. |
FLAVOXATE HYDROCHLORIDE
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLAVOXATE HYDROCHLORIDE | FLAVOXATE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076835 | EPIC PHARMA |
FLAVOXATE HYDROCHLORIDE | FLAVOXATE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076831 | PADAGIS US |