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FDA Drug Approval Applications Sponsored by JANSSEN PHARMS

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
015923 New Drug Application Approval New formulation (S) Standard review drug
016954 New Drug Application Approval New formulation (S) Standard review drug
017481 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017577 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
017735 New Drug Application Approval New manufacturer (S) Standard review drug
017919 New Drug Application Approval New formulation (S) Standard review drug
018533 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
018701 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
018985 New Drug Application Approval New formulation (S) Standard review drug
019037 New Drug Application Approval New formulation (S) Standard review drug
019579 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019641 New Drug Application Approval New formulation (S) Standard review drug
019653 New Drug Application Approval New molecular entity (NME); New combination (S) Standard review drug
019697 New Drug Application Approval New formulation (S) Standard review drug
019735 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019813 New Drug Application Approval New ester, new salt, or other noncovalent derivative; New formulation (S) Standard review drug
019927 New Drug Application Approval New formulation (S) Standard review drug
019964 New Drug Application Approval New manufacturer (S) Standard review drug
020083 New Drug Application Approval New molecular entity (NME) (P*) Priority review drug*
020193 New Drug Application Approval New molecular entity (NME) (S) Standard review drug (V) Orphan drug
020210 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020229 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020272 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020281 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020301 New Drug Application Approval New manufacturer (S) Standard review drug
020398 New Drug Application Approval New formulation (S) Standard review drug
020505 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020588 New Drug Application Approval New formulation (S) Standard review drug
020634 New Drug Application Approval New formulation (S) Standard review drug
020635 New Drug Application Approval New formulation (S) Standard review drug
020657 New Drug Application Approval New formulation (P) Priority review drug
020844 New Drug Application Approval New formulation (S) Standard review drug
020897 New Drug Application Approval New formulation (S) Standard review drug
020966 New Drug Application Approval New formulation (S) Standard review drug
021001 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021121 New Drug Application Approval New formulation (S) Standard review drug
021123 New Drug Application Approval New combination (S) Standard review drug
021169 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021180 New Drug Application Approval New molecular entity (NME); New combination (S) Standard review drug
021224 New Drug Application Approval New formulation (S) Standard review drug
021241 New Drug Application Approval New formulation (S) Standard review drug
021346 New Drug Application Approval New formulation
021444 New Drug Application Approval New formulation (S) Standard review drug
021615 New Drug Application Approval New formulation (S) Standard review drug
021721 New Drug Application Approval New formulation (S) Standard review drug
021999 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022264 New Drug Application Approval New formulation (S) Standard review drug
022406 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022523 New Drug Application Approval Drug already marketed, but without an approved NDA (S) Standard review drug
085055 Abbreviated New Drug Application Approval
088790 Abbreviated New Drug Application Approval
202439 New Drug Application Approval 10
204042 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
204353 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
205879 New Drug Application Approval New combination (S) Standard review drug
207946 New Drug Application Approval New manufacturer (P) Priority review drug
208398 New Drug Application Approval New manufacturer

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