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AstraZeneca Pharmaceuticals LP

Pharmaceutical companyAI in United StatesAI. FDA records under 12 spellings of its name, each linked to the record. See the AstraZeneca group view.

  • Records across the group: 138, 9 entitiesAI
  • Drug applications: 113
  • Drug recalls: 12
  • OPDP letters: 8
  • 510(k) clearances: 3

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, AstraZeneca Pharmaceuticals LP and its 8 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Oct 10, 2025Complete response letter, BLA 761451UnapprovedComplete response letters
Sep 23, 2025Untitled letter: FARXIGAOffice of Prescription Drug PromotionOPDP letters
Sep 9, 2025Untitled letter: TRUQAPOffice of Prescription Drug PromotionOPDP letters
Sep 9, 2025Untitled letter: FASENRAOffice of Prescription Drug PromotionOPDP letters
Sep 9, 2025Untitled letter: FASENRAOffice of Prescription Drug PromotionOPDP letters
Sep 9, 2025Untitled letter: FASENRAOffice of Prescription Drug PromotionOPDP letters
Sep 9, 2025Untitled letter: CALQUENCEOffice of Prescription Drug PromotionOPDP letters
Sep 9, 2025Untitled letter: ULTOMIRISOffice of Prescription Drug PromotionOPDP letters
May 14, 2025Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-Class II · Defective delivery systemDrug recalls
Aug 4, 2023Warning letter: BREZTRI AEROSPHEREOffice of Prescription Drug PromotionOPDP letters
Sep 30, 2019Complete response letter, NDA 212122ApprovedComplete response letters
Jan 12, 1990ASTRA DISPOSABLE SPRAY CANNULAK894755 · CCT510(k) clearances
Jul 2, 1985ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRINK851903 · EJI510(k) clearances
Feb 1, 1979ASTRA-VACK782115 · GCY510(k) clearances

Subsidiaries and Divisions

8 firms in the AstraZeneca Pharmaceuticals LP group, most records first

Canada and Imports

Across the AstraZeneca Pharmaceuticals LP group, matched by company name
FDA import refusals since 2024
49 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
ASTRAZENECAASTRAZENECA ABAstraZeneca Pharmaceuticals LPAstraZeneca LPASTRAZENECA LPAstraZenecaAstraZeneca ABAstraZeneca Pharmaceuticals, LPASTRAZENECA PHARMACEUTICALSASTRAZENECA PHARMS
Wikidata
Q731938

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.