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USDMF
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 : 1846
Submission : 1971-12-22
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-14
DMF Number : 10185
Submission : 1993-04-12
Status :
Type : II
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-02
Pay. Date : 2013-09-18
DMF Number : 24913
Submission : 2011-05-25
Status :
Type : II
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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-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**Federa...DOSAGE - TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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-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- 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 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**Federal R...DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
USFDA APPLICATION NUMBER - 203696
DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG
USFDA APPLICATION NUMBER - 203696
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 - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
USFDA APPLICATION NUMBER - 20870
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
USFDA APPLICATION NUMBER - 20870
DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal ...DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20907
DOSAGE - TABLET;ORAL - 1MG;0.5MG
USFDA APPLICATION NUMBER - 20907
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 - 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
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