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FDA Daily

FDA daily for Tuesday, September 8, 2026

170 FDA records across 3 sections. 10 touch MedGrid's categories and are listed first.

170FDA Records
3 of 7Sections With Data
10Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Mon, Sep 7 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Tue, Sep 1 (a week ago)
1 touch MedGrid8
  • LIDOCAINE HYDROCHLORIDE AND EPINEPHRINETouches MedGrid categories

    EPINEPHRINE, LIDOCAINE HYDROCHLORIDE — B BRAUN MEDICAL

    ANDA208475 · Labeling

  • DOXEPIN HYDROCHLORIDE

    DOXEPIN HYDROCHLORIDE — LEADING

    ANDA211619 · Labeling

  • FULVICIN P/G 330

    GRISEOFULVIN, ULTRAMICROSIZE — CHARTWELL RX

    ANDA061996 · Labeling

  • NELARABINE

    NELARABINE — MEITHEAL

    ANDA216038 · Labeling

  • NEVIRAPINE

    NEVIRAPINE — MYLAN

    ANDA205651 · Labeling

  • KRAZATI

    ADAGRASIB — BRISTOL

    NDA216340 · Labeling

  • BYOOVIZ

    RANIBIZUMAB-NUNA — SAMSUNG BIOEPIS CO LTD

    BLA761202 · Labeling

  • CLEOCIN HYDROCHLORIDE

    CLINDAMYCIN HYDROCHLORIDE — PFIZER

    NDA050162 · Labeling

Drug recallsCovers FDA's Tue, Sep 1 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Tue, Sep 1 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Tue, Sep 1 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Tue, Aug 25 (two weeks ago)
10
  • Inno-Switch™ Laparoscopic Instruments

    Taiwan Surgical Corporation

    K252535 · Substantially Equivalent · General, Plastic Surgery

  • Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)

    SteriLance Medical (Suzhou), Inc.

    K262631 · Substantially Equivalent · General, Plastic Surgery

  • Ceevra Reveal 4

    Ceevra, Inc.

    K261595 · Substantially Equivalent · Radiology

  • Promisemed X-Safety Pen Needle

    Promisemed Hangzhou Meditech Co., Ltd.

    K261719 · Substantially Equivalent · General Hospital

  • Calcium Hydroxide Temporary Filling Material (KP-Cal)

    Guilin Kevin Peter Technology Co., Ltd.

    K261514 · Substantially Equivalent · Dental

  • Report Studio

    Beacon Biosignals, Inc.

    K261747 · Substantially Equivalent · Neurology

  • MONOFIX PDO

    Samyang Holdings Corporation

    K253879 · Substantially Equivalent · General, Plastic Surgery

  • iNOS intraoral biosensor

    Achaemenid, LLC

    K254304 · Substantially Equivalent · Dental

  • Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System

    Abbott Diabetes Care

    DEN250049 · Unknown · Clinical Chemistry

  • SOL-M Luer Lock Syringe with Exchangeable Needle Tray

    Sol-Millennium Medical, Inc.

    K252184 · Substantially Equivalent · General Hospital

Label changesCovers FDA's Tue, Aug 25 (two weeks ago)
9 touch MedGrid152
  • LidoSpraTouches MedGrid categories

    Oncora Pharma, LLC

    Label version 2

  • Depo-ProveraTouches MedGrid categories

    Pharmacia & Upjohn Company LLC

    Label version 29

  • LidomarTouches MedGrid categories

    Oncora Pharma, LLC

    Label version 3

  • Juyasuyon Sport Ultra Sunscreen CreamTouches MedGrid categories

    Guangdong Aimu Biological Technology Co., Ltd

    Label version 1

  • JUYASUYON Sport Ultra SunscreenTouches MedGrid categories

    Guangdong Aimu Biological Technology Co., Ltd

    Label version 1

  • Q Skin ScienceTouches MedGrid categories

    International Cosmeceuticals, Inc

    Label version 1

  • ISNTREE HYALURONIC ACID WATERY SUNSCREENTouches MedGrid categories

    ISNTREE Inc.

    Label version 1

  • Inknows Lidocaine Pain Relief Gel-PatchTouches MedGrid categories

    Henan Enokon Medical Instrument Co., Ltd.

    Label version 1

  • Foot Pain Relief PadsTouches MedGrid categories

    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

    Label version 1

  • TRIAMCINOLONE ACETONIDE

    Bryant Ranch Prepack

    Label version 101

  • Icosapent Ethyl

    Bryant Ranch Prepack

    Label version 2

  • Clobetasol Propionate

    Bryant Ranch Prepack

    Label version 101

Showing 12 of 152. Search the rest in openFDA.

How the FDA Daily Is WrittenSources, dates and what gets flagged

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug recalls, device recalls and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Items that touch the categories MedGrid works in, such as GLP-1s, hormones, injectables, peptides, compounded products and aesthetic devices, are marked and listed first.

Subscribe with any feed reader, or point an email tool at theRSS feed. For the rules behind the headlines, see Regulations Research.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.