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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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PharmaCompass

01

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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02

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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03

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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04

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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05

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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06

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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07

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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08

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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09

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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10

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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11

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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12

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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13

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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14

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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15

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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16

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

blank

17

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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18

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

blank

19

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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

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20

Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

ZALEPLON

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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