Calendar

Week of Sep 6, 2021

Sep 10, 2021approval1797d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: LUPIN LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

Sep 10, 2021approval1797d agoQDOLO (TRAMADOL HYDROCHLORIDE) — FDA approvaltramadol hydrochloride ER

Sponsor: ROSEMONT. Form: SOLUTION. Route: ORAL

Sep 10, 2021approval1797d agoCONZIP (TRAMADOL HYDROCHLORIDE) — FDA approvalTrigen Laboratories Inc

Sponsor: CIPHER PHARMS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

Sep 10, 2021approval1797d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

Sep 13, 2021approval1794d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: CONCENTRATE. Route: ORAL

Sep 15, 2021approval

Sep 20, 2021approval1787d agoFLUOXETINE HYDROCHLORIDE — FDA approvalFLUOXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

Sep 20, 2021approval

Sep 27, 2021approval1780d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

Sponsor: GENUS. Form: SYRUP. Route: ORAL

Sep 28, 2021approval

Oct 4, 2021approval1773d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

Oct 4, 2021approval

Oct 13, 2021approval1764d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

Oct 13, 2021approval

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