Drugs@FDA: FDA-Approved Drugs
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. |
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10/28/2011 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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03/09/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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02/19/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
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05/29/2001 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/20/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/24/2001 | SUPPL-10 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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05/24/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/24/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/07/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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10/31/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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06/04/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/27/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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02/21/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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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 | 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 PHARMA |
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 |