FDA.reportPublic FDA data

Application 073261

Type
ANDA
Sponsor
RADIUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULINDACSULINDACTABLET; ORAL150MGNoNo

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 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SULINDACSULINDACA-S Medication Solutions6041acc2-5e8a-4d3c-bf50-7e9447748e2b2026-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SULINDAC
generic name: SULINDAC
SULINDACSULINDACA-S Medication Solutionsf4985b1b-7e2c-4911-897a-94c337794bab2026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SULINDAC
generic name: SULINDAC
SULINDACSULINDACPuraCap Laboratories LLC dba Blu Pharmaceuticals0feabf47-8d0d-48c0-b263-43db4969f39e2025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SULINDAC
generic name: SULINDAC
SULINDACSULINDACPD-Rx Pharmaceuticals, Inc.eb7acb87-6565-4524-a91a-02064ea8bd1a2025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SULINDAC
generic name: SULINDAC
SULINDACSULINDACPD-Rx Pharmaceuticals, Inc.1fffe88d-50c8-45cf-ac7c-a62b665c89a82025-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SULINDAC
generic name: SULINDAC
SulindacSULINDACPD-Rx Pharmaceuticals, Inc.68d4eeed-2501-494b-b979-502720de86c02025-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sulindac
generic name: SULINDAC
SULINDACSULINDACEpic Pharma, LLC96c73bd2-4577-487d-a642-bd8f91e94c3a2024-12-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SULINDAC
generic name: SULINDAC
SULINDACSULINDACSun Pharmaceutical Industries, Inc.a47e4259-d44b-4b7b-b517-841cb68409822024-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SULINDAC
generic name: SULINDAC
SulindacSULINDACActavis Pharma, Inc.d8b9d517-5dd4-4c6b-8aa0-736bce87e7b42024-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sulindac
generic name: SULINDAC
SULINDACSULINDACProficient Rx LPd94e8865-d151-4fb1-bacd-f4e43819e3c22022-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SULINDAC
generic name: SULINDAC