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Teva Pharmaceutical Industries

Generic drug makerAI in IsraelAI. FDA records under 2 spellings of its name, each linked to the record. See the Teva group view.

  • Records across the group: 3,327, 54 entitiesAI
  • Drug applications: 2,938
  • Drug recalls: 369
  • Complete response letters: 10
  • 510(k) clearances: 7

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Teva Pharmaceutical Industries and its 53 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Sep 9, 2025Untitled letter: AUSTEDO XROffice of Prescription Drug PromotionOPDP letters
Sep 9, 2025Untitled letter: AUSTEDO XROffice of Prescription Drug PromotionOPDP letters
Sep 21, 2018TEVADAPTOR Closed Drug Reconstitution and Transfer SystemK180489 · ONB510(k) clearances
May 16, 2017TEVADAPTOR Closed Drug Reconstitution and Transfer SystemK170680 · ONB510(k) clearances
Apr 5, 2017Warning letter: Process validation, Stability, Out-of-specificationCDERWarning letters
Jan 23, 2015TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEMK141448 · ONB510(k) clearances
Jun 12, 2014TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITEK141306 · FPA510(k) clearances
Dec 18, 2012Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Class II · Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. DissolutiDrug recalls
Feb 24, 1999FREE FLOW SAFETY DEVICE, MODEL MG 245052K990288 · FPA510(k) clearances
Dec 19, 1997COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONSK974171 · KZH510(k) clearances
Sep 19, 1995MARSAM MODEL 2000 NEBULIZERK933961 · CAF510(k) clearances

Subsidiaries and Divisions

53 firms in the Teva Pharmaceutical Industries group, most records first

Canada and Imports

Across the Teva Pharmaceutical Industries group, matched by company name
FDA import refusals since 2024
11 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
TEVATeva Pharmaceutical Industries

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.