FDA.reportPublic FDA data

Application 208276

Type
NDA
Sponsor
UNITED THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REMODULINTREPROSTINILSOLUTION;INTRAVENOUS, SUBCUTANEOUS20MG/20ML (1MG/ML)NoNo
002REMODULINTREPROSTINILSOLUTION;INTRAVENOUS, SUBCUTANEOUS50MG/20ML (2.5MG/ML)NoNo
003REMODULINTREPROSTINILSOLUTION;INTRAVENOUS, SUBCUTANEOUS100MG/20ML (5MG/ML)NoNo
004REMODULINTREPROSTINILSOLUTION;INTRAVENOUS, SUBCUTANEOUS200MG/20ML (10MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208276-001REMODULINTREPROSTINIL20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS, SUBCUTANEOUS2018-07-30
N208276-002REMODULINTREPROSTINIL50MG/20ML (2.5MG/ML)SOLUTION / INTRAVENOUS, SUBCUTANEOUS2018-07-30
N208276-003REMODULINTREPROSTINIL100MG/20ML (5MG/ML)SOLUTION / INTRAVENOUS, SUBCUTANEOUS2018-07-30
N208276-004REMODULINTREPROSTINIL200MG/20ML (10MG/ML)SOLUTION / INTRAVENOUS, SUBCUTANEOUS2018-07-30

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208276-00195930662028-12-15Drug substance2018-11-02
N208276-00295930662028-12-15Drug substance2018-11-02
N208276-00395930662028-12-15Drug substance2018-11-02
N208276-00495930662028-12-15Drug substance2018-10-01

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 22:54:322026-06N208276-001REMODULIN20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS, SUBCUTANEOUS2018-07-30a50c72e98297…
2026-08-01 22:54:322026-06N208276-002REMODULIN50MG/20ML (2.5MG/ML)SOLUTION / INTRAVENOUS, SUBCUTANEOUS2018-07-30a50c72e98297…
2026-08-01 22:54:322026-06N208276-003REMODULIN100MG/20ML (5MG/ML)SOLUTION / INTRAVENOUS, SUBCUTANEOUS2018-07-30a50c72e98297…
2026-08-01 22:54:322026-06N208276-004REMODULIN200MG/20ML (10MG/ML)SOLUTION / INTRAVENOUS, SUBCUTANEOUS2018-07-30a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208276-00195930662028-12-15Drug substance2018-11-02a50c72e98297…
2026-08-01 22:54:322026-06N208276-00295930662028-12-15Drug substance2018-11-02a50c72e98297…
2026-08-01 22:54:322026-06N208276-00395930662028-12-15Drug substance2018-11-02a50c72e98297…
2026-08-01 22:54:322026-06N208276-00495930662028-12-15Drug substance2018-10-01a50c72e98297…

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 · 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
brand name: Remodulin
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
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
generic name: TREPROSTINIL
TreprostinilTREPROSTINILTeva Parenteral Medicines, Inc.4b2ce4aa-4302-49db-9456-c8cf0e0349682022-05-01Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55081ORIG2018-08-03
55067ORIG2018-07-31
58352ORIG2018-07-30