Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 2Biophore India Pharmaceuticals Pvt Ltd
02 2Strides Pharma Science
03 1Aizant Drug Research Solutions Pvt. Ltd.
04 1Annora Pharma
05 3CHIESI USA INC
06 1Lupin Ltd
07 1Rising Pharmaceuticals Inc
08 1Teva Pharmaceutical Industries
01 1Extended-Release Tablet
02 7TABLET, EXTENDED RELEASE;ORAL
03 2TABLET;ORAL
04 2Tablet
01 4DISCN
02 5RX
03 3Blank
01 6ZILEUTON
02 2ZYFLO
03 1ZYFLO CR
04 3Blank
01 3India
02 9USA
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 600MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ZILEUTON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 600MG
Packaging :
Approval Date : 2019-12-16
Application Number : 212670
Regulatory Info : RX
Registration Country : USA
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 600MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Extended-Release Tablet
Dosage Strength : 600MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ZILEUTON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 600MG
Packaging :
Approval Date : 2020-10-23
Application Number : 211390
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZILEUTON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 600MG
Packaging :
Approval Date : 2022-10-11
Application Number : 215742
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZYFLO
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG
Packaging :
Approval Date : 1996-12-09
Application Number : 20471
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZYFLO
Dosage Form : TABLET;ORAL
Dosage Strength : 600MG
Packaging :
Approval Date : 1996-12-09
Application Number : 20471
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZYFLO CR
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2007-05-30
Application Number : 22052
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZILEUTON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 600MG
Packaging :
Approval Date : 2019-11-05
Application Number : 211972
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZILEUTON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 600MG
Packaging :
Approval Date : 2017-03-17
Application Number : 204929
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZILEUTON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 600MG
Packaging :
Approval Date : 2022-05-03
Application Number : 211043
Regulatory Info : DISCN
Registration Country : USA
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