Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074625
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/31/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2012 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2012 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/03/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/17/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1996 | SUPPL-1 | Labeling |
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 | 213550 | BEXIMCO PHARMS USA |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212798 | LEADING |
| 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 | 209025 | RISING |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 075079 | STRIDES PHARMA |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208165 | 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 |