FDA.reportPublic FDA data

Application 205699

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BOSENTANBOSENTANTABLET;ORAL62.5MGNoNo
002BOSENTANBOSENTANTABLET;ORAL125MGNoNo

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
A205699-001BOSENTANBOSENTAN62.5MGTABLET / ORAL2019-04-26
A205699-002BOSENTANBOSENTAN125MGTABLET / ORAL2019-04-26

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 22:54:322026-06A205699-001BOSENTAN62.5MGTABLET / ORAL2019-04-26a50c72e98297…
2026-08-01 22:54:322026-06A205699-002BOSENTAN125MGTABLET / ORAL2019-04-26a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BosentanBOSENTANZydus Pharmaceuticals USA Inc.8444da17-6c31-492b-8842-93740f083d9d2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bosentan
generic name: BOSENTAN
bosentanBOSENTANZydus Lifesciences Limitedb88cc559-93ae-42db-9c38-fb5e9c4802e62026-02-14Name fallback
brand name: bosentan
generic name: BOSENTAN
BosentanBOSENTANSun Pharmaceutical Industries, Inc.c006d8ef-8cb7-4fb3-88eb-b2debc302a202025-12-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bosentan
generic name: BOSENTAN
bosentanBOSENTANActavis Pharma, Inc.39b2a85f-4322-42d4-b420-1b1d525691432025-11-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bosentan
generic name: BOSENTAN
TracleerBOSENTANActelion Pharmaceuticals US, Inc.749e42fb-2fe0-45dd-9268-b43bb3f4081c2025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BOSENTAN
bosentanBOSENTANZydus Pharmaceuticals USA Inc.c1e75179-cbea-4535-8709-f6d79c1d40042025-11-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bosentan
generic name: BOSENTAN
BosentanBOSENTANLupin Pharmaceuticals, Inc.540b6f6a-79f3-4681-8c2a-268cf7cecbc92025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bosentan
generic name: BOSENTAN
BosentanBOSENTANZydus Lifesciences Limited02892f47-0d59-4254-9ee7-d524278fdd792024-11-25Name fallback
brand name: Bosentan
generic name: BOSENTAN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-058BosentanBosentanPar Pharmaceutical, Inc.ANDACurrent
49884-058BosentanBosentanPar Pharmaceutical, Inc.ANDACurrent
49884-058BosentanBosentanPar Pharmaceutical, Inc.ANDACurrent
49884-058BosentanBosentanPar Pharmaceutical, Inc.ANDACurrent
49884-059BosentanBosentanPar Pharmaceutical, Inc.ANDACurrent
49884-059BosentanBosentanPar Pharmaceutical, Inc.ANDACurrent
49884-059BosentanBosentanPar Pharmaceutical, Inc.ANDACurrent
49884-059BosentanBosentanPar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76406ORIG 2023-11-06
58805ORIG2019-05-21