Synopsis
Synopsis
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10519
Submission : 1993-10-08
Status : Inactive
Type : II
Details:
Undisclosed
Lead Product(s): Danaparoid sodium,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Undisclosed
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 18, 2019
Lead Product(s) : Danaparoid sodium,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
January 18, 2019
RLD : No
TE Code :
Brand Name : ORGARAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 750 UNITS/0.6ML
Approval Date : 1996-12-24
Application Number : 20430
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Regulatory Info :
Registration Country : Sweden
Brand Name : Orgaran
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING
Dosage Strength : 1250 ANTI-XA E/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Canada
Brand Name : ORGARAN
Dosage Form : SOLUTION
Dosage Strength : 750UNIT/0.6ML
Packaging : 10X0.6ML AMPS
Approval Date :
Application Number : 2129043
Regulatory Info :
Registration Country : Canada
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