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FDA Drug Approval Applications Sponsored by GENZYME

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
020057 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020367 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020898 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020926 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021179 New Drug Application Approval New formulation (S) Standard review drug
021673 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
022127 New Drug Application Approval New formulation (S) Standard review drug
022311 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
022318 New Drug Application Approval New formulation (S) Standard review drug
075721 Abbreviated New Drug Application Approval
103948 Biologic License Application Approval
103979 Biologic License Application Approval
125141 Biologic License Application Approval
125291 Biologic License Application Approval

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