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01 2Adamed Pharma
02 2Aurobindo Pharma Limited
03 2BIOFUTURA PHARMA SpA
04 2Chartwell Pharmaceuticals llc
05 4Hikma Pharmaceuticals
06 4Meda Ab
07 2Meda Pharmaceuticals Inc.
08 2Natco Pharma
09 1Nile Pharma
10 2OrBion Pharmaceuticals
11 2Orchid Pharma
12 2Pfizer Inc
13 2Teva Pharmaceutical Industries
14 2Unichem Laboratories Limited
15 2Unichem Pharmaceuticals USA, Inc
16 4Upsher-Smith Laboratories
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01 2CAPSULE
02 22CAPSULE;ORAL
03 7Capsule
04 2HARD CAPSULE
05 4Blank
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01 12DISCN
02 4Deregistered
03 4Generic
04 2Generic EU CTD
05 10RX
06 5Blank
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01 1Easysleep
02 2SONATA
03 4Sonata
04 20ZALEPLON
05 4Zerene
06 6Blank
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01 1Egypt
02 4India
03 4Italy
04 2Poland
05 4Sweden
06 22USA
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 : 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 : DISCN
Registration Country : USA
Brand Name : SONATA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 1999-08-13
Application Number : 20859
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SONATA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 1999-08-13
Application Number : 20859
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 : 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 : 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