FDA.reportPublic FDA data

Application 208906

Type
ANDA
Sponsor
ACTAVIS LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TREPROSTINILTREPROSTINILTABLET, EXTENDED RELEASE;ORAL0.125MGNoNo
002TREPROSTINILTREPROSTINILTABLET, EXTENDED RELEASE;ORAL0.25MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
TYVASOTREPROSTINILUnited Therapeutics Corporationcbc31ab1-a80f-4b50-a3b1-39910b0fb6092026-04-14Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
Tyvaso DPITREPROSTINILUnited Therapeutics Corporationddc3d400-bcb3-4b09-aae2-0768b10a5b0f2025-11-20Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
YutrepiaTREPROSTINILLiquidia Technologies, Inc.e8f6d534-115c-440e-bdbb-b443a29bb4682025-09-08Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
TreprostinilTREPROSTINILAlembic Pharmaceuticals Inc.4a684b13-669d-4721-8ed4-30cc7762b0b82025-02-13Warnings, Adverse reactionsName fallback
brand name: Treprostinil
generic name: TREPROSTINIL
OrenitramTREPROSTINILUnited Therapeutics Corporation8ed2003a-c801-411e-831e-d06079bb0d7c2024-11-20Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsName fallback
brand name: Treprostinil
generic name: TREPROSTINIL
TreprostinilTREPROSTINILTeva Parenteral Medicines, Inc.4b2ce4aa-4302-49db-9456-c8cf0e0349682022-05-01Warnings, Adverse reactionsName fallback
brand name: Treprostinil
generic name: TREPROSTINIL
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsName fallback
brand name: Treprostinil
generic name: TREPROSTINIL

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74153ORIG 2023-05-02