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FDA Daily

FDA daily for Tuesday, September 29, 2026

34 FDA records across 3 sections. 1 touches MedGrid's categories and is listed first.

34FDA Records
3 of 7Sections With Data
1Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Mon, Sep 28 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Tue, Sep 22 (a week ago)
1 touch MedGrid15
  • KETAMINE HYDROCHLORIDETouches MedGrid categories

    KETAMINE HYDROCHLORIDE — EUGIA PHARMA

    ANDA076092 · Manufacturing (CMC)

  • CARBON DIOXIDE, USP

    CARBON DIOXIDE, USP — AGL WELDING SUPPLY CO INC DBA AGL GAS TECHNOLOGIES

    NDA222000 · Original approval

  • EMPAGLIFLOZIN

    EMPAGLIFLOZIN — INVAGEN PHARMS

    ANDA212330 · Original approval

  • RISPERIDONE

    RISPERIDONE — PHARMAZONE

    ANDA077328 · Manufacturing (CMC)

  • PANTOPRAZOLE SODIUM

    PANTOPRAZOLE SODIUM — RUBICON RESEARCH

    ANDA090807 · Labeling

  • NUBEQA

    DAROLUTAMIDE — BAYER HEALTHCARE

    NDA212099 · Labeling

  • MYCOPHENOLATE SODIUM

    MYCOPHENOLATE SODIUM — APOTEX INC

    ANDA091558 · Labeling

  • TELMISARTAN AND AMLODIPINE

    AMLODIPINE BESYLATE, TELMISARTAN — ALEMBIC

    ANDA205234 · Manufacturing (CMC)

  • ATORVASTATIN CALCIUM

    ATORVASTATIN CALCIUM — INVAGEN PHARMS

    ANDA204846 · Labeling

  • AMLODIPINE BESYLATE

    AMLODIPINE BESYLATE — IPCA LABS LTD

    ANDA210489 · Original approval

  • HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

    HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATE — PHARMAZONE

    ANDA220509 · Original approval

  • PREXXARTAN

    VALSARTAN — CARMEL BIOSCIENCES

    NDA209139 · Labeling

Showing 12 of 15. Search the rest in openFDA.

Drug recallsCovers FDA's Tue, Sep 22 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Tue, Sep 22 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Tue, Sep 22 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Tue, Sep 15 (two weeks ago)
12
  • Artificial Intelligence Renal Assessment (AIRA) Version 1

    Aramis Global AI Consultancies, LLC

    K261677 · Substantially Equivalent · Radiology

  • CVAC® Aspiration System

    Calyxo, Inc.

    K261447 · Substantially Equivalent · Gastroenterology, Urology

  • Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)

    Zhenjiang Assure Medical Equipment Co., Ltd.

    K260141 · Substantially Equivalent · Physical Medicine

  • SPINEsim v1.0

    Mdsim S.A.

    K261861 · Substantially Equivalent · Radiology

  • TMC Implant Fixation System

    Treace Medical Concepts, Inc.

    K262963 · Substantially Equivalent · Orthopedic

  • YJ-K1K2 Wheelchair (YJ-013F)

    Zhenjiang Assure Medical Equipment Co., Ltd.

    K260145 · Substantially Equivalent · Physical Medicine

  • Tontarra Punches and Rongeurs

    Tontarra Medizintechnik GmbH

    K260446 · Substantially Equivalent · Neurology

  • LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated

    Covidien, LLC

    K261070 · Substantially Equivalent · General, Plastic Surgery

  • GMK Extension

    Medacta International SA

    K262057 · Substantially Equivalent · Orthopedic

  • Reclining wheelchair (YJ-013L)

    Zhenjiang Assure Medical Equipment Co., Ltd.

    K260144 · Substantially Equivalent · Physical Medicine

  • CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45…

    Karl Storz SE & CO. KG

    K254299 · Substantially Equivalent · Ear, Nose, Throat

  • OOOPDS

    Taiwan Main Orthopaedic Biotechnology Co., Ltd.

    K254214 · Substantially Equivalent · Radiology

Label changesCovers FDA's Tue, Sep 15 (two weeks ago)
7
  • Doxycycline Hyclate

    REMEDYREPACK INC.

    Label version 2

  • Drug label

    Label version 7

  • spironolactone

    REMEDYREPACK INC.

    Label version 5

  • Drug label

    Label version 2

  • Drug label

    Label version 2

  • Drug label

    Label version 6

  • Drug label

    Label version 6

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.