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Accord Healthcare

Generic drug makerAI in United StatesAI, part of Intas PharmaceuticalsAI. FDA records under 7 spellings of its name, each linked to the record.

  • Drug applications: 165
  • Drug recalls: 106
  • Complete response letters: 7

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Aug 6, 2026Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 1672Class II · Subpotent DrugDrug recalls
Aug 6, 2026Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 276Class II · Subpotent DrugDrug recalls
Aug 6, 2026Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2Class II · Subpotent DrugDrug recalls
Aug 6, 2026Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27Class II · Subpotent DrugDrug recalls
Aug 6, 2026Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-4Class II · Subpotent DrugDrug recalls
Aug 6, 2026Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617Class II · Subpotent DrugDrug recalls
Aug 6, 2026Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27Class II · Subpotent DrugDrug recalls
Aug 6, 2026Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27Class II · Subpotent DrugDrug recalls
Nov 6, 2025Complete response letter, NDA 216987UnapprovedComplete response letters
Dec 5, 2024Complete response letter, NDA 218762UnapprovedComplete response letters
May 10, 2024Complete response letter, NDA 216987UnapprovedComplete response letters
Apr 17, 2024Complete response letter, NDA 218762UnapprovedComplete response letters
Mar 7, 2024Complete response letter, NDA 215749UnapprovedComplete response letters
Jan 30, 2024Complete response letter, NDA 218470UnapprovedComplete response letters
Apr 30, 2021Complete response letter, NDA 215000ApprovedComplete response letters

Canada and Imports

Matched by company name
FDA import refusals since 2024
2 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
ACCORD HLTHCAREAccord Healthcare, Inc.ACCORD HEALTHCARE, INC.ACCORD HLTHCARE INCAccord Healthcare Inc.ACCORD

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.