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FDA Drug Approval Applications Sponsored by MYLAN INSTITUTIONAL

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
016763 New Drug Application Approval New ester, new salt, or other noncovalent derivative (P) Priority review drug (V) Orphan drug
017788 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019677 New Drug Application Approval New combination (S) Standard review drug
019678 New Drug Application Approval New manufacturer (S) Standard review drug
019832 New Drug Application Approval New formulation (S) Standard review drug (V) Orphan drug
020298 New Drug Application Approval New formulation (P) Priority review drug (V) Orphan drug
020615 New Drug Application Approval New formulation (S) Standard review drug (V) Orphan drug
020630 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021624 New Drug Application Approval
040451 Abbreviated New Drug Application Approval
040471 Abbreviated New Drug Application Approval
040498 Abbreviated New Drug Application Approval
040541 Abbreviated New Drug Application Approval
040647 Abbreviated New Drug Application Approval
040652 Abbreviated New Drug Application Approval
050517 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
062757 Abbreviated New Drug Application Approval
063182 Abbreviated New Drug Application Approval
065371 Abbreviated New Drug Application Approval
076092 Abbreviated New Drug Application Approval
076185 Abbreviated New Drug Application Approval
076217 Abbreviated New Drug Application Approval
076428 Abbreviated New Drug Application Approval
076474 Abbreviated New Drug Application Approval
076488 Abbreviated New Drug Application Approval
077998 Abbreviated New Drug Application Approval
078639 Abbreviated New Drug Application Approval
078980 Abbreviated New Drug Application Approval
079033 Abbreviated New Drug Application Approval
079198 Abbreviated New Drug Application Approval
079199 Abbreviated New Drug Application Approval
088873 Abbreviated New Drug Application Approval
090270 Abbreviated New Drug Application Approval
090299 Abbreviated New Drug Application Approval
090394 Abbreviated New Drug Application Approval
090574 Abbreviated New Drug Application Approval
090643 Abbreviated New Drug Application Approval
090664 Abbreviated New Drug Application Approval
090874 Abbreviated New Drug Application Approval
090924 Abbreviated New Drug Application Approval
091623 Abbreviated New Drug Application Approval
091657 Abbreviated New Drug Application Approval
200752 Abbreviated New Drug Application Approval
201276 Abbreviated New Drug Application Approval
202493 Abbreviated New Drug Application Approval
202626 Abbreviated New Drug Application Approval
202881 Abbreviated New Drug Application Approval
203554 Abbreviated New Drug Application Approval
203624 Abbreviated New Drug Application Approval
204404 Abbreviated New Drug Application Approval
204634 Abbreviated New Drug Application Approval
204680 Abbreviated New Drug Application Approval
204879 Abbreviated New Drug Application Approval
204949 Abbreviated New Drug Application Approval
204997 Abbreviated New Drug Application Approval
205014 Abbreviated New Drug Application Approval
205239 Abbreviated New Drug Application Approval
206404 Abbreviated New Drug Application Approval

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