Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210125
Company: TULEX PHARMS INC
Company: TULEX PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | 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 |
---|---|---|---|---|---|---|---|
09/06/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
OXYBUTYNIN CHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209335 | ABHAI LLC |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209025 | APPCO |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212798 | LEADING PHARMA LLC |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 210611 | NOVAST LABS |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209823 | NOVITIUM PHARMA |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 075079 | STRIDES PHARMA |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 071655 | TEVA PHARMS USA |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 210125 | TULEX PHARMS INC |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074625 | UPSHER SMITH LABS |
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