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 2OrBion Pharmaceuticals
09 2Orchid Pharma
10 2Pfizer Inc
11 2Teva Pharmaceutical Industries
12 2Unichem Laboratories Limited
13 2Unichem Pharmaceuticals USA, Inc
14 4Upsher-Smith Laboratories
01 2CAPSULE
02 22CAPSULE;ORAL
03 2Capsule
04 2HARD CAPSULE
05 4Blank
01 10DISCN
02 4Generic
03 2Generic EU CTD
04 12RX
05 4Blank
01 2SONATA
02 2Sonata
03 20ZALEPLON
04 2Zerene
05 6Blank
01 4India
02 4Italy
03 2Poland
04 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 : 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 : 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
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