Calendar

Week of Mar 30, 2015

Mar 30, 2015approval4150d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

Mar 31, 2015approval4149d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

Mar 31, 2015approval4149d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: INJECTABLE. Route: INJECTION

Mar 31, 2015approval4149d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

Apr 2, 2015approval4147d agoERRIN (NORETHINDRONE) — FDA approvalNaari USA Inc

Sponsor: DR REDDYS LABS SA. Form: TABLET. Route: ORAL-28

Apr 3, 2015approval4146d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL

Apr 3, 2015approval4146d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL

Apr 6, 2015approval4143d agoDIGOXIN — FDA approvalHikma Pharmaceuticals USA Inc

Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL

Apr 6, 2015approval

Apr 13, 2015approval4136d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL

Apr 14, 2015approval

Apr 20, 2015approval4129d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

Apr 20, 2015approval

page 15 of 632