FDA.reportPublic FDA data

Application 075730

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THIOTEPATHIOTEPAINJECTABLE;INJECTION15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002THIOTEPATHIOTEPAINJECTABLE;INJECTION30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075730-001THIOTEPATHIOTEPA15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION2001-04-20
A075730-002THIOTEPATHIOTEPA30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION2001-04-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075730-001THIOTEPA15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION2001-04-20a50c72e98297…
2026-08-01 22:54:322026-06A075730-002THIOTEPA30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION2001-04-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TEPADINATHIOTEPAAmneal Pharmaceuticals LLC559e353c-2dc0-16ba-e054-00144ff8d46c2026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: THIOTEPA
ThiotepaTHIOTEPAGland Pharma Limited6cd6ae89-c553-4328-9262-4363610a1f192026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
ThiotepaTHIOTEPASagent Pharmaceuticals448c29f1-6d9c-4f8e-8a69-9b85e973e7282025-10-20Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
TEPYLUTETHIOTEPAShorla Oncology Inc.add44e98-a042-4e38-b870-beb36693805b2025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: THIOTEPA
ThiotepaTHIOTEPANovadoz Pharmaceuticals LLCb702dcc9-dd0e-4386-b1e2-f20562fd2ad92024-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
ThiotepaTHIOTEPAMeitheal Pharmaceuticals Inc4b4725eb-95f1-45cc-852f-152beb5f1e2c2023-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
ThiotepaTHIOTEPAHikma Pharmaceuticals USA Inc.9ae8063c-ba28-4da2-a94c-8e1a5f75e4b32023-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
ThiotepaTHIOTEPAHikma Pharmaceuticals USA Inc.6dc898dc-5949-4aa4-83f8-4bd20c29eb932023-05-24Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
ThiotepaTHIOTEPADr.Reddy's Laboratories Inc.,a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb2022-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
ThiotepaTHIOTEPAFresenius Kabi USA, LLC493410f3-0733-4f76-8050-6529d96f2a5b2022-03-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
ThiotepaTHIOTEPAHikma Pharmaceuticals USA Inc.b19b03db-471d-4ee7-b1b8-6eccc39c41b02021-04-02Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA
ThiotepaTHIOTEPADr.Reddy's Laboratories Inc.,0def6a5e-4bf5-b1fd-47b7-0f17ecfd9bc22018-04-25Warnings, Adverse reactionsName fallback
brand name: Thiotepa
generic name: THIOTEPA

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8778ORIG2001-04-20