Calendar

Week of Jun 14, 2021

Jun 14, 2021approval1883d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

Jun 14, 2021approval1883d agoLIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% (LIDOCAINE HYDROCHLORIDE) — FDA approvalLaryng-O-Jet

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Laryng-O-Jet →fda approvals ↗

Jun 14, 2021approval1883d agoVALTREX (VALACYCLOVIR HYDROCHLORIDE) — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

Jun 14, 2021approval1883d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLIN ER →fda approvals ↗

Jun 14, 2021approval1883d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLIN ER →fda approvals ↗

Jun 15, 2021approval1882d agoPROSCAR (FINASTERIDE) — FDA approvalPROSCAR

Sponsor: ORGANON. Form: TABLET. Route: ORAL

full page →PROSCAR →fda approvals ↗

Jun 15, 2021approval1882d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 16, 2021approval1881d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: NANG KUANG PHARM CO. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Jun 17, 2021approval1880d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗

Jun 17, 2021approval1880d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Jun 17, 2021approval1880d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗

Jun 17, 2021approval1880d agoLEVORPHANOL TARTRATE — FDA approvalSpecGx LLC

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jun 17, 2021approval1880d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗

Jun 17, 2021approval1880d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗

Jun 17, 2021approval1880d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗

Jun 17, 2021approval1880d agoASTEPRO ALLERGY (AZELASTINE HYDROCHLORIDE) — FDA approvalWallace Pharmaceuticals Inc

Sponsor: BAYER HLTHCARE. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Jun 17, 2021approval1880d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Jun 17, 2021approval1880d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Week of Jun 21, 2021

Jun 21, 2021approval1876d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Jun 21, 2021approval

Week of Jun 28, 2021

Jun 28, 2021approval1869d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

Jun 28, 2021approval

Week of Jul 5, 2021

Jul 6, 2021approval1861d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

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