Calendar · pharmadog

Sign In Subscribe

Week of Apr 6, 2026

41

Apr 10, 2026approval91d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval91d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

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

full page →LOSARTAN POTASSIUM →fda approvals ↗

Apr 10, 2026approval91d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval91d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval91d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval91d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval91d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval91d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

Apr 10, 2026approval91d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval91d 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 ↗

Apr 10, 2026approval91d agoDILTIAZEM HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval91d agoMETHYLPREDNISOLONE — FDA approvalMEDROL

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗

Apr 10, 2026approval91d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: STRIDES PHARMA INTL. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Apr 10, 2026device 510k91d agoAscblue Corporation — Ascblue (8010) (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoDk Medical Systems Co., Ltd. — AeroDR TX c02 (510k cleared)

Product code: KPR. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoPlasma Surgical, Inc. — ARION ARC System (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoSophysa — Pressio 3 Multi-parameter Neuromonitoring System (510k cleared)

Product code: GWM. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d ago1987 Media Limited — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) (510k cleared)

Product code: OBR. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoOkami Medical, Inc. — LOBO Vascular Occlusion System (510k cleared)

Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d ago3Shape TRIOS A/S — TRIOS Dx (R1) (510k cleared)

Product code: SHQ. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoActis Medical Pty., Ltd. — SMART Osteotomy System (510k cleared)Atticus Medical Pty Ltd

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoRelu BV — Relu Cloud (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoUniversity of Utah, Department of Orthopaedics — CoAptix S System (510k cleared)University of Utah

Product code: HWC. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoAitewan Biomedical Technology, Inc. — DeepBT Detector-Plus (510k cleared)

Product code: QKB. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoShanghai Draeger Medical Instrument Co., Ltd. — Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (510k cleared)

Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoShenB Co., Ltd. — Diacore (510k cleared)

Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoBecton, Dickinson and Company — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube (510k cleared)BECTON DICKINSON & CO

Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoOverjet, Inc. — Overjet Iris Intelligent Imaging System (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoShaeferh, LLC — ShaeferH (510k cleared)

Product code: LRK. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoBecton, Dickinson and Company — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder (510k cleared)BECTON DICKINSON & CO

Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoCovidien (Part of Medtronic) — Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads (510k cleared)

Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoSiemens Healthcare GmbH — syngo Dynamics (VA41F) (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Teleport Glide Microcatheter (510k cleared)

Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoMedela, LLC — Freestyle Mini Hands-free (510k cleared)

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoCequr SA — CeQur Simplicity On-Demand Insulin Delivery System (510k cleared)Shanghai Jiao Tong University

Product code: OPP. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoCognifisense, Inc. — VRNT (510k cleared)

Product code: QRA. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoSiemens Healthcare GmbH — AI-Rad Companion Organs RT (510k cleared)

Product code: QKB. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoProtaryx Medical, Inc. — Protaryx Transseptal Puncture Device (PTX2-001) (510k cleared)

Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoEximo Medical — Auryon Atherectomy System (510k cleared)

Product code: MCW. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoBelport Company, Inc., Gingi-Pak — Porcelain Etch Gel (510k cleared)

Product code: KLE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k91d agoRadiometer Medicals Aps — ABL90 FLEX PLUS System, safeCLINITUBES (510k cleared)

Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Week of Apr 13, 2026

9

Apr 13, 2026approval88d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Apr 13, 2026approval

← prev

page 1 of 3