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FDA Drug Approval Applications Sponsored by BAYER HLTHCARE

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
007012 New Drug Application Approval
016000 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
016647 New Drug Application Approval New formulation (S) Standard review drug
017575 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
018181 New Drug Application Approval New manufacturer (S) Standard review drug
018713 New Drug Application Approval New formulation (S) Standard review drug
018714 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
019537 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
019580 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019596 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
019847 New Drug Application Approval New formulation (S) Standard review drug
019857 New Drug Application Approval New formulation (S) Standard review drug
020220 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020304 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020375 New Drug Application Approval New manufacturer (S) Standard review drug
020482 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020780 New Drug Application Approval New formulation (S) Standard review drug
020807 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020860 New Drug Application Approval New formulation (S) Standard review drug
021037 New Drug Application Approval New formulation (S) Standard review drug
021085 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021098 New Drug Application Approval New molecular entity (NME); New combination (S) Standard review drug
021225 New Drug Application Approval New formulation (S) Standard review drug
021258 New Drug Application Approval New combination (S) Standard review drug
021277 New Drug Application Approval New formulation (S) Standard review drug
021355 New Drug Application Approval New combination (S) Standard review drug
021400 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021425 New Drug Application Approval New formulation (S) Standard review drug
021470 New Drug Application Approval New formulation (S) Standard review drug
021473 New Drug Application Approval New formulation (S) Standard review drug
021674 New Drug Application Approval New indication (S) Standard review drug
021676
YAZ
New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
021844 New Drug Application Approval New formulation (S) Standard review drug
021873
YAZ
New Drug Application Approval New indication (S) Standard review drug
021923 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
022045
YAZ
New Drug Application Approval New indication (S) Standard review drug
022090 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022252 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022532 New Drug Application Approval New combination (S) Standard review drug
022574 New Drug Application Approval New manufacturer (S) Standard review drug
085978 Abbreviated New Drug Application Approval
086099 Abbreviated New Drug Application Approval
087723 Abbreviated New Drug Application Approval
087724 Abbreviated New Drug Application Approval
087725 Abbreviated New Drug Application Approval
087726 Abbreviated New Drug Application Approval
087728 Abbreviated New Drug Application Approval
087729 Abbreviated New Drug Application Approval
087731 Abbreviated New Drug Application Approval
087739 Abbreviated New Drug Application Approval
087768 Abbreviated New Drug Application Approval
200179 New Drug Application Approval New formulation (S) Standard review drug
201277 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
203085 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
203159 New Drug Application Approval New manufacturer (S) Standard review drug
203971 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
204819 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
205352 New Drug Application Approval New combination (S) Standard review drug
207071 New Drug Application Approval New formulation (S) Standard review drug
208224 New Drug Application Approval New manufacturer (S) Standard review drug

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