Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071655
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| 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 |
|---|---|---|---|---|---|---|---|
| 11/14/1988 | 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 |
|---|---|---|---|---|---|
| 06/13/2012 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2011 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/29/2001 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/20/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/2001 | SUPPL-10 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/24/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/21/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/15/1994 | SUPPL-1 | Manufacturing (CMC) |
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 | 074625 | AIPING PHARM INC |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 211682 | HERITAGE PHARMA AVET |
| 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 | 213550 | REGCON HOLDINGS |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209025 | RISING |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208165 | STRIDES PHARMA |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 075079 | STRIDES PHARMA INTL |
| 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 | TP ANDA HOLDINGS |