Synopsis
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KDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-20
Pay. Date : 2020-03-24
DMF Number : 26020
Submission : 2012-05-02
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2425
Submission : 1975-03-27
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-04
Pay. Date : 2012-11-14
DMF Number : 3803
Submission : 1980-05-20
Status :
Type : II
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Certificate Number : R0-CEP 2020-029 - Rev 00
Status : Valid
Issue Date : 2021-10-06
Type : Chemical
Substance Number : 140
Aspen API. More than just an API.
Certificate Number : R2-CEP 1995-022 - Rev 05
Status : Valid
Issue Date : 2014-01-30
Type : Chemical
Substance Number : 140
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API Imports and Exports
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Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL-28 - 0.02MG;1MG
USFDA APPLICATION NUMBER - 17354
DOSAGE - TABLET;ORAL-21 - 0.03MG;1.5MG
USFDA APPLICATION NUMBER - 17355
DOSAGE - TABLET;ORAL-28 - 0.03MG;0.3MG **Fede...DOSAGE - TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17802
DOSAGE - TABLET;ORAL-21 - 0.03MG;1.5MG
USFDA APPLICATION NUMBER - 17875
DOSAGE - TABLET;ORAL-21 - 0.02MG;1MG **Federa...DOSAGE - TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17876
DOSAGE - TABLET;ORAL-28 - 0.035MG;1MG **Feder...DOSAGE - TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17919
DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.0...DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
USFDA APPLICATION NUMBER - 18977
DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.0...DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18985
DOSAGE - TABLET;ORAL-28 - 0.035MG;0.25MG **Fe...DOSAGE - TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19653
DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.0...DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19697
DOSAGE - TABLET;ORAL-21 - 0.02MG,0.03MG,0.035...DOSAGE - TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20130
DOSAGE - TABLET;ORAL-21 - 0.15MG;0.03MG **Fed...DOSAGE - TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20301
DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal R...DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 203667
DOSAGE - TABLET;ORAL - 0.02MG,0.15MG;0.025MG,...DOSAGE - TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A
USFDA APPLICATION NUMBER - 204061
DOSAGE - CAPSULE;ORAL - 0.02MG;1MG
USFDA APPLICATION NUMBER - 204426
DOSAGE - TABLET, CHEWABLE, TABLET;ORAL - 0.01...DOSAGE - TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
USFDA APPLICATION NUMBER - 204654
DOSAGE - TABLET;ORAL - 0.02MG;0.1MG
USFDA APPLICATION NUMBER - 208612
DOSAGE - RING;VAGINAL - 0.013MG/24HR;0.15MG/2...DOSAGE - RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR
USFDA APPLICATION NUMBER - 209627
DOSAGE - TABLET;ORAL - 0.0025MG;0.5MG
USFDA APPLICATION NUMBER - 21065
DOSAGE - TABLET;ORAL - 0.005MG;1MG **Federal ...DOSAGE - TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21065
DOSAGE - TABLET;ORAL-28 - 0.1MG,0.125MG,0.15M...DOSAGE - TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
USFDA APPLICATION NUMBER - 21090
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21180
DOSAGE - RING;VAGINAL - 0.015MG/24HR;0.12MG/2...DOSAGE - RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR
USFDA APPLICATION NUMBER - 21187
DOSAGE - TABLET;ORAL-28 - 0.025MG,0.025MG,0.0...DOSAGE - TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21241
DOSAGE - TABLET;ORAL - 0.035MG;0.4MG **Federa...DOSAGE - TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21490
DOSAGE - TABLET;ORAL - 3MG;0.02MG
USFDA APPLICATION NUMBER - 21676
DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal R...DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21871
DOSAGE - TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A
USFDA APPLICATION NUMBER - 22501
DOSAGE - TABLET, CHEWABLE;ORAL - 0.025MG;0.8M...DOSAGE - TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG
USFDA APPLICATION NUMBER - 22573
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