01 2Adamed Pharma
02 2Aurobindo Pharma Limited
03 2BIOFUTURA PHARMA SpA
04 2Chartwell Pharmaceuticals llc
05 4Hikma Pharmaceuticals
06 2Meda Pharmaceuticals Inc.
07 2Natco Pharma
08 1Nile Pharma
09 2OrBion Pharmaceuticals
10 2Orchid Pharma
11 2Pfizer Inc
12 2Teva Pharmaceutical Industries
13 2Unichem Laboratories Limited
14 2Unichem Pharmaceuticals USA, Inc
15 4Upsher-Smith Laboratories
01 2CAPSULE
02 22CAPSULE;ORAL
03 3Capsule
04 2HARD CAPSULE
05 4Blank
01 10DISCN
02 4Generic
03 2Generic EU CTD
04 12RX
05 5Blank
01 1Easysleep
02 2SONATA
03 2Sonata
04 20ZALEPLON
05 2Zerene
06 6Blank
01 1Egypt
02 4India
03 4Italy
04 2Poland
05 22USA
Regulatory Info : Generic
Registration Country : Poland
Brand Name :
Dosage Form : HARD CAPSULE
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Poland
Regulatory Info : Generic
Registration Country : Poland
Brand Name :
Dosage Form : HARD CAPSULE
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Poland
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-06
Application Number : 78829
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-06
Application Number : 78829
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-20
Application Number : 77505
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-20
Application Number : 77505
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-06
Application Number : 77237
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-06
Application Number : 77237
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-11-25
Application Number : 78147
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-11-25
Application Number : 78147
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Sonata
Dosage Form :
Dosage Strength : 14 Cps 5 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-06
Application Number : 77238
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-06
Application Number : 77238
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2009-09-17
Application Number : 90374
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2009-09-17
Application Number : 90374
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Generic EU CTD
Registration Country : India
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic EU CTD
Registration Country : India
Regulatory Info : Generic EU CTD
Registration Country : India
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic EU CTD
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : SONATA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 1999-08-13
Application Number : 20859
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SONATA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1999-08-13
Application Number : 20859
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-06
Application Number : 77239
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-06
Application Number : 77239
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-06
Application Number : 78989
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-06
Application Number : 78989
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-06
Application Number : 78095
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-06
Application Number : 78095
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2008-06-06
Application Number : 78706
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZALEPLON
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2008-06-06
Application Number : 78706
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Zerene
Dosage Form :
Dosage Strength : 14 Cps 5 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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