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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21140
Submission : 2007-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27360
Submission : 2003-04-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27515
Submission : 2003-03-26
Status : Inactive
Type : II
Registration Number : 301MF10020
Registrant's Address : Eckenheimer Landstrasse 100, 60318 Frankfurt am Main, Germany
Initial Date of Registration : 2019-06-25
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27515
Submission : 2003-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27360
Submission : 2003-04-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21140
Submission : 2007-12-17
Status : Active
Type : II
RLD :
TE Code :
Brand Name : DYSPORT
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 500 UNITS/VIAL
Approval Date :
Application Number : 125274
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DYSPORT
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 300 UNITS/VIAL
Approval Date :
Application Number : 125274
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : Xeomin
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50 UNITS/VIAL
Approval Date :
Application Number : 125360
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : Xeomin
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 100 UNITS/VIAL
Approval Date :
Application Number : 125360
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : Xeomin
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 200 UNITS/VIAL
Approval Date :
Application Number : 125360
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Botox
Dosage Form : Trockensub
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Botox
Dosage Form : Trockensub
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Botox
Dosage Form : Trockensub
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Dysport
Dosage Form : Dry Sub
Dosage Strength : 500iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Dysport
Dosage Form : Dry Sub
Dosage Strength : 300iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xeomin
Dosage Form : Trockensub
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xeomin
Dosage Form : Trockensub
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : DYSPORT AESTHETIC
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 300UNIT/VIAL
Packaging : 3ML
Approval Date :
Application Number : 2387735
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : DYSPORT THERAPEUTIC
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 300UNIT/VIAL
Packaging : 1 VIAL
Approval Date :
Application Number : 2460203
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : DYSPORT THERAPEUTIC
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 500UNIT/VIAL
Packaging : 3ML
Approval Date :
Application Number : 2456117
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Botox
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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