Suppliers and packages for NDA: 078503
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078503
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
---|---|---|---|---|---|---|---|---|---|
Osmotica Pharm Us | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | AvKARE | 42291-633-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-633-01) | 2016-03-09 |
Osmotica Pharm Us | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | AvKARE | 42291-633-50 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-633-50) | 2016-03-09 |
Osmotica Pharm Us | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | AvKARE | 42291-634-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-01) | 2016-03-09 |
Osmotica Pharm Us | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | AvKARE | 42291-634-50 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-50) | 2016-03-09 |
Osmotica Pharm Us | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | AvKARE | 42291-635-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-635-01) | 2016-03-09 |
Osmotica Pharm Us | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-790-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-790-90) | 2009-03-01 |
Osmotica Pharm Us | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-282-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-30) | 2016-03-09 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |