Drugs@FDA: FDA-Approved Drugs
Company: OSMOTICA PHARM US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
02/04/2009 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078503Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/09/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
09/09/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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11/04/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
08/30/2013 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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08/30/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
04/07/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
OXYBUTYNIN CHLORIDE
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207138 | ACCORD HLTHCARE |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211655 | AJANTA PHARMA LTD |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204010 | AMNEAL PHARMS |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210717 | BIONPHARMA |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078503 | OSMOTICA PHARM US |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214415 | RUBICON |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206121 | UNIQUE |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202332 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207138 | ACCORD HLTHCARE |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211655 | AJANTA PHARMA LTD |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204010 | AMNEAL PHARMS |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210717 | BIONPHARMA |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078503 | OSMOTICA PHARM US |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214415 | RUBICON |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206121 | UNIQUE |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202332 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207138 | ACCORD HLTHCARE |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211655 | AJANTA PHARMA LTD |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204010 | AMNEAL PHARMS |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210717 | BIONPHARMA |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078503 | OSMOTICA PHARM US |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214415 | RUBICON |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206121 | UNIQUE |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202332 | ZYDUS PHARMS |