Calendar

Week of Jun 26, 2023

Jun 26, 2023approval1143d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 26, 2023approval1143d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 26, 2023approval1143d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 26, 2023approval1143d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 26, 2023approval1143d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 26, 2023approval1143d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 26, 2023approval1143d agoRYSTIGGO (ROZANOLIXIZUMAB-NOLI) — FDA approvalrozanolixizumab

Sponsor: UCB INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →rozanolixizumab →fda approvals ↗

Jun 26, 2023approval1143d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗

Jun 26, 2023approval1143d agoHADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →HADLIMA →fda approvals ↗

Jun 28, 2023approval1141d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗

Jun 28, 2023approval1141d agoCAPLYTA (LUMATEPERONE TOSYLATE) — FDA approvallumateperone tosylate

Sponsor: INTRA-CELLULAR. Form: CAPSULE. Route: ORAL

full page →lumateperone tosylate →fda approvals ↗

Jun 29, 2023approval1140d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jun 29, 2023approval1140d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →guselkumab →fda approvals ↗

Jun 30, 2023approval1139d agoGAVRETO (PRALSETINIB) — FDA approvalRIGEL PHARMACEUTICALS INC

Sponsor: RIGEL PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jun 30, 2023approval1139d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION

full page →CYLTEZO →fda approvals ↗

Week of Jul 3, 2023

Jul 3, 2023approval1136d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: TABLET. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

Jul 3, 2023approval

Week of Jul 10, 2023

Jul 10, 2023approval1129d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Jul 10, 2023approval

Week of Jul 17, 2023

Jul 17, 2023approval1122d agoBEYFORTUS (NIRSEVIMAB-ALIP) — FDA approvalnirsevimab

Sponsor: ASTRAZENECA AB. Form: INJECTABLE. Route: INJECTION

full page →nirsevimab →fda approvals ↗

Jul 17, 2023approval

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