Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075079
Company: STRIDES PHARMA INTL
Company: STRIDES PHARMA INTL
| 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 |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 2.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1997 | 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 |
|---|---|---|---|---|---|
| 09/15/2021 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/13/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/01/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/23/2006 | SUPPL-4 | 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 | 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 |
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 209025 | RISING |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075079 | STRIDES PHARMA INTL |