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01 1Aspen Pharmacare Holdings

02 1Aurobindo Pharma Limited

03 2Cristalia Produtos Quimicos Farma. Ltda

04 4ENDO OPERATIONS

05 2ENDO OPERATIONS LTD.

06 1Eagle Pharmaceuticals

07 3Elite Laboratories

08 2Hikma Pharmaceuticals

09 3Impax Laboratories

10 1Meda Pharmaceuticals Inc.

11 1Pfizer Consumer Healthcare

12 2Pharmaco Distribution

13 1US WorldMeds

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PharmaCompass

01

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AAN
Not Confirmed

Dantrolene

Brand Name : Dantrium vial 20mg

Dosage Form : INJ

Dosage Strength : 20mg

Packaging : 12X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

02

AAN
Not Confirmed
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AAN
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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03

AAN
Not Confirmed
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AAN
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

AAN
Not Confirmed
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AAN
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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05

AAN
Not Confirmed
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AAN
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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06

AAN
Not Confirmed
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AAN
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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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07

AAN
Not Confirmed
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AAN
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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08

AAN
Not Confirmed
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AAN
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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09

AAN
Not Confirmed
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AAN
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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10

AAN
Not Confirmed
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AAN
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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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11

AAN
Not Confirmed
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AAN
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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12

AAN
Not Confirmed
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AAN
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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13

AAN
Not Confirmed
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AAN
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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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14

AAN
Not Confirmed
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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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15

AAN
Not Confirmed
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Dantrolene

Brand Name : Dantrium

Dosage Form :

Dosage Strength :

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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16

AAN
Not Confirmed
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AAN
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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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17

AAN
Not Confirmed
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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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18

AAN
Not Confirmed
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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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19

ENDO OPERATIONS

Country
AAN
Not Confirmed
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ENDO OPERATIONS

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AAN
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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ENDO OPERATIONS

Country
AAN
Not Confirmed
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ENDO OPERATIONS

Country
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AAN
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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21

ENDO OPERATIONS

Country
AAN
Not Confirmed
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ENDO OPERATIONS

Country
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AAN
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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ENDO OPERATIONS

Country
AAN
Not Confirmed
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ENDO OPERATIONS

Country
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AAN
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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23

ENDO OPERATIONS LTD.

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AAN
Not Confirmed
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ENDO OPERATIONS LTD.

Country
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AAN
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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24

ENDO OPERATIONS LTD.

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AAN
Not Confirmed
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ENDO OPERATIONS LTD.

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AAN
Not Confirmed

DANTROLENE SODIUM

Brand Name : DANTRIUM INTRAVENOUS

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 20MG/VIAL

Packaging :

Approval Date :

Application Number : 1997572

Regulatory Info : Prescription

Registration Country : Canada

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