Home Applications 217236 Application 217236
Type ANDA
Sponsor PATHEON SOFTGELS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN CAPSULE;ORAL EQ 200MG FREE ACID AND POTASSIUM SALT No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217236-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2024-02-13
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A217236-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2024-02-13 a50c72e98297…
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 48 · 956 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN REMEDYREPACK INC. 2572ed69-d5a7-4513-a202-aca3230e7ec5 2026-07-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Pioneer Life Sciences, LLC 8abd74a4-ad33-4c10-b677-acb469f815e6 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Amneal Pharmaceuticals LLC 17577b3b-e755-45d1-8b53-775d058578b2 2026-07-29 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NUVICARE LLC b063d2dc-d579-46e7-8cfc-1596c803c7f9 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN Amazon.com Services LLC b5a47efe-222f-4cbd-b649-caafd16a0829 2026-07-29 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN Harris Teeter 637210f0-6494-4656-8b2b-14d7476cb127 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN Harris Teeter 9d5c994a-8363-4ddb-956c-e12b79a32a58 2026-07-29 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN Harris Teeter 87ffbf01-54de-45a8-b2a3-367d21927882 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN Harris Teeter 14515409-736f-4119-b6a0-cb19ee2e948e 2026-07-29 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN Harris Teeter 1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc633 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN ADVIL MIGRAINE IBUPROFEN Haleon US Holdings LLC e4a6219d-4ad4-0119-4cf8-7fc39b4b5979 2026-07-29 Warnings Name fallback generic name: IBUPROFEN Advil IBUPROFEN Haleon US Holdings LLC 1f01c10a-9434-91a4-2ee4-352315a6b610 2026-07-29 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Pioneer Life Sciences, LLC 291602fa-8ebe-4200-bba7-9798c90f8a50 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NUVICARE LLC 7905edc1-2a45-4adc-a7bc-42b1ddb6ba59 2026-07-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN H E B 21567c0f-abba-4a40-a0b9-5ce49b3d9648 2026-07-28 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN PD-Rx Pharmaceuticals, Inc. 656658cc-8cf0-42b6-af4f-4e3ab7648625 2026-07-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN REMEDYREPACK INC. a7756b22-73cf-4262-aa8e-0577ddecd03b 2026-07-24 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Shield Pharmaceuticals Corp 1ca722bb-940e-4b3e-9561-d87e2feb1ff8 2026-07-24 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Shield Pharmaceuticals Corp fc6c29b4-f1b3-4cfe-8c96-564d083be39c 2026-07-24 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN childrens ibuprofen IBUPROFEN Rite Aid Corporation 26bccfc1-bc8d-4241-a078-c760048951c9 2026-07-24 Warnings Name fallback generic name: IBUPROFEN