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01 1Aurobindo Pharma Limited

02 2Cristalia Produtos Quimicos Farma. Ltda

03 4ENDO OPERATIONS

04 1Eagle Pharmaceuticals

05 3Elite Laboratories

06 2Endo Pharm

07 2Hikma Pharmaceuticals

08 3Impax Laboratories

09 1Meda Pharmaceuticals Inc.

10 1Pfizer Consumer Healthcare

11 2Pharmaco Distribution

12 1US WorldMeds

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/VIAL

Packaging :

Approval Date : 2016-02-18

Application Number : 205239

Regulatory Info : DISCN

Registration Country : USA

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dantrolene Sodium

Brand Name : DANTROLENE

Dosage Form : INJECTION

Dosage Strength : 20MG

Packaging : 12 VIALS + 12 AMPS OIL

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Brazil

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dantrolene Sodium

Brand Name : DANTROLENE

Dosage Form : INJECTION

Dosage Strength : 20MG

Packaging : 12 VIALS + 12 AMPS OIL

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Brazil

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : RYANODEX

Dosage Form : FOR SUSPENSION;INTRAVENOUS

Dosage Strength : 250MG/VIAL

Packaging :

Approval Date : 2014-07-22

Application Number : 205579

Regulatory Info : RX

Registration Country : USA

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2005-10-24

Application Number : 76686

Regulatory Info : RX

Registration Country : USA

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2005-10-24

Application Number : 76686

Regulatory Info : RX

Registration Country : USA

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2005-10-24

Application Number : 76686

Regulatory Info : RX

Registration Country : USA

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTRIUM CAPSULES

Dosage Form : CAPSULE

Dosage Strength : 25MG

Packaging : 100

Approval Date :

Application Number : 1997602

Regulatory Info : Prescription

Registration Country : Canada

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09

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTRIUM INTRAVENOUS

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 20MG/VIAL

Packaging : 20MG

Approval Date :

Application Number : 1997572

Regulatory Info : Prescription

Registration Country : Canada

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10

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/VIAL

Packaging :

Approval Date : 2017-06-19

Application Number : 204762

Regulatory Info : RX

Registration Country : USA

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11

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM FOR INJECTION, USP

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 20MG/VIAL

Packaging :

Approval Date :

Application Number : 2529998

Regulatory Info : Prescription

Registration Country : Canada

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12

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 2005-03-01

Application Number : 76856

Regulatory Info : RX

Registration Country : USA

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13

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2005-03-01

Application Number : 76856

Regulatory Info : RX

Registration Country : USA

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14

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTROLENE SODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2005-03-01

Application Number : 76856

Regulatory Info : RX

Registration Country : USA

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15

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dantrolene

Brand Name : Dantrium iv

Dosage Form : INJ

Dosage Strength : 20mg/vial

Packaging : 1X1mg/vial

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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16

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

dantrolene

Brand Name : Dantrium

Dosage Form :

Dosage Strength :

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dantrolene

Brand Name : Dantrium

Dosage Form : CAP

Dosage Strength : 25mg

Packaging : 50X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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18

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Dantrolene

Brand Name : Dantrium iv

Dosage Form : INJ

Dosage Strength : 3000mg/vial

Packaging : 1X1mg/vial

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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19

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : REVONTO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/VIAL

Packaging :

Approval Date : 2007-07-24

Application Number : 78378

Regulatory Info : RX

Registration Country : USA

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20

ENDO OPERATIONS

Country
Antibody Engineering
Not Confirmed
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ENDO OPERATIONS

Country
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTRIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Packaging :

Approval Date : 1982-01-01

Application Number : 17443

Regulatory Info : RX

Registration Country : USA

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21

ENDO OPERATIONS

Country
Antibody Engineering
Not Confirmed
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ENDO OPERATIONS

Country
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTRIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 1982-01-01

Application Number : 17443

Regulatory Info : RX

Registration Country : USA

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22

ENDO OPERATIONS

Country
Antibody Engineering
Not Confirmed
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ENDO OPERATIONS

Country
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Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTRIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 1982-01-01

Application Number : 17443

Regulatory Info : RX

Registration Country : USA

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23

ENDO OPERATIONS

Country
Antibody Engineering
Not Confirmed
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ENDO OPERATIONS

Country
arrow
Antibody Engineering
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTRIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/VIAL

Packaging :

Approval Date : 1982-01-01

Application Number : 18264

Regulatory Info : RX

Registration Country : USA

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