Calendar

pharmadog

Week of Oct 20, 2025

Oct 22, 2025approval312d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 22, 2025approval312d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 22, 2025approval312d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 22, 2025approval312d agoOXALIPLATIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 22, 2025approval312d agoCONTEPO (FOSFOMYCIN DISODIUM) — FDA approvalfosfomycin disodium

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →fosfomycin disodium →fda approvals ↗

Oct 22, 2025approval312d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 22, 2025approval312d agoVISINE (NAPHAZOLINE HYDROCHLORIDE) — FDA approval

Sponsor: KENVUE BRANDS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Oct 22, 2025approval312d agoLOFEXIDINE HYDROCHLORIDE — FDA approvalLOFEXIDINE HYDROCHLORIDE

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

full page →LOFEXIDINE HYDROCHLORIDE →fda approvals ↗

Oct 22, 2025approval312d agoARIPIPRAZOLE — FDA approvalaripiprazole LA

Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL

full page →aripiprazole LA →fda approvals ↗

Oct 23, 2025approval311d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: CADILA. Form: TABLET. Route: ORAL

full page →VORICONAZOLE →fda approvals ↗

Oct 23, 2025approval311d agoOMVOH (MIRIKIZUMAB-MRKZ) — FDA approvalmirikizumab

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →mirikizumab →fda approvals ↗

Oct 23, 2025approval311d agoJAVADIN (CLONIDINE HYDROCHLORIDE) — FDA approvalclonidine hydrochloride

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →clonidine hydrochloride →fda approvals ↗

Oct 23, 2025approval311d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: DR REDDYS LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Oct 23, 2025approval311d agoDALBAVANCIN HYDROCHLORIDE — FDA approvalFresenius Kabi USA LLC

Sponsor: TEVA PHARMS INC. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 23, 2025approval311d agoVORICONAZOLE — FDA approvalMylan Pharmaceuticals Inc

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

full page →fda approvals ↗

Oct 23, 2025approval311d agoBLENREP (BELANTAMAB MAFODOTIN-BLMF) — FDA approvalbelantamab mafodotin

Sponsor: GLAXOSMITHKLINE LLC. Form: INJECTABLE. Route: INJECTION

full page →belantamab mafodotin →fda approvals ↗

Oct 23, 2025approval311d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

Oct 23, 2025approval311d agoDEHYDRATED ALCOHOL — FDA approval

Sponsor: ROYAL PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 23, 2025approval311d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalDESIPRAMINE HYDROCHLORIDE

Sponsor: INGENUS PHARMS LLC. Form: TABLET. Route: ORAL

full page →DESIPRAMINE HYDROCHLORIDE →fda approvals ↗

Oct 23, 2025approval311d agoDOCOSANOL — FDA approvalPL Developments Copiague LLC

Sponsor: DR REDDYS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Oct 23, 2025approval311d agoQUINAPRIL HYDROCHLORIDE — FDA approvalLupin Ltd

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 23, 2025approval311d agoQUINAPRIL HYDROCHLORIDE — FDA approvalLupin Ltd

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 23, 2025approval311d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

Oct 23, 2025approval311d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: AUROBINDO PHARMA. Form: SOLUTION. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

Oct 23, 2025approval311d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: ACTAVIS LABS FL. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 23, 2025approval311d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: ACTAVIS LABS FL. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 24, 2025approval310d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Oct 24, 2025approval310d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →sotatercept →fda approvals ↗

Oct 24, 2025approval310d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Oct 24, 2025approval310d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 24, 2025approval310d agoTRAMADOL HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 24, 2025approval310d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 24, 2025approval310d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

Sponsor: HIKMA. Form: SOLUTION. Route: INTRAVENOUS

full page →ATROPINE SULFATE →fda approvals ↗

Oct 24, 2025approval310d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 24, 2025approval310d agoANASTROZOLE — FDA approvalStason Pharmaceuticals Inc

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

full page →fda approvals ↗

Oct 24, 2025approval310d agoLEFLUNOMIDE — FDA approvalLEFLUNOMIDE

Sponsor: HERITAGE. Form: TABLET. Route: ORAL

full page →LEFLUNOMIDE →fda approvals ↗

Oct 24, 2025approval310d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗

Oct 24, 2025approval310d agoLYNKUET (ELINZANETANT) — FDA approvalBayer USA LLC

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

full page →fda approvals ↗

Oct 24, 2025approval310d agoREVUFORJ (REVUMENIB CITRATE) — FDA approvalrevumenib citrate

Sponsor: SYNDAX. Form: TABLET. Route: ORAL

full page →revumenib citrate →fda approvals ↗

Oct 24, 2025approval310d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 24, 2025approval310d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →(empagliflozin + linagliptin) →fda approvals ↗

Oct 24, 2025approval310d agoLETROZOLE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: HIKMA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 24, 2025approval310d agoANASTROZOLE — FDA approvalANASTROZOLE

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →ANASTROZOLE →fda approvals ↗

Oct 24, 2025approval310d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Oct 24, 2025approval310d agoTRIJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin + metformin hydrochloride) ER

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + linagliptin + metformin hydrochloride) ER →fda approvals ↗

Oct 24, 2025approval310d agoROCURONIUM BROMIDE — FDA approvalROCURONIUM BROMIDE

Sponsor: B BRAUN MEDICAL. Form: SOLUTION. Route: INTRAVENOUS

full page →ROCURONIUM BROMIDE →fda approvals ↗

Oct 24, 2025approval310d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Oct 24, 2025approval310d agoNEOSTIGMINE METHYLSULFATE — FDA approvalNEOSTIGMINE METHYLSULFATE

Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: INTRAVENOUS

full page →NEOSTIGMINE METHYLSULFATE →fda approvals ↗

Oct 24, 2025approval310d agoRIVAROXABAN — FDA approvalRIVAROXABAN

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →RIVAROXABAN →fda approvals ↗

Oct 24, 2025approval310d agoANASTROZOLE — FDA approvalANASTROZOLE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ANASTROZOLE →fda approvals ↗

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Week of Oct 20, 2025