Home Applications 214071 Application 214071
Type ANDA
Sponsor STRIDES PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN SUSPENSION/DROPS;ORAL 50MG/1.25ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A214071-001 IBUPROFEN IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09
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 2026-09-14 22:38:34 2026-08 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214071-001 IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL 2022-06-09 a50c72e98297…
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 40 of 47 · 926 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Best Choice (Valu Merchandisers Company) 04b4ed2b-5f43-4151-b355-ca1bb469658d 2023-08-31 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions fa99f5ec-0306-473b-827f-86cd0a7978ec 2023-08-31 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen minis IBUPROFEN Care One (Retail Business Services, LLC.) b5e9bd39-d2c5-4a6c-b0da-8e41d633b31c 2023-08-24 Warnings Name fallback generic name: IBUPROFEN Good Neighbor Pharmacy ibuprofen IBUPROFEN Amerisource Bergen 74b227c9-8341-44df-a763-cfeb371c0d28 2023-08-17 Warnings Name fallback generic name: IBUPROFEN Ibuprofen minis IBUPROFEN Strategic Sourcing Services LLC c363c80f-364a-4047-a246-a1fdeb98a4f0 2023-08-08 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN TABLETS USP, 200MG BETTER LIVING BRANDS, LLC eb60a1e5-fb6e-360f-e053-2a95a90ade04 2023-08-03 Warnings Name fallback brand name: Ibuprofen betr remedies ibuprofen IBUPROFEN Live Betr LLC 0a50820f-1dfa-45b5-824f-2c28822fc6c6 2023-07-26 Warnings Name fallback generic name: IBUPROFEN Good Sense Ibuprofen IBUPROFEN L. Perrigo Company f9af5970-18ca-46d5-8d6c-c0fec22a66d5 2023-07-21 Warnings Name fallback generic name: IBUPROFEN good sense ibuprofen IBUPROFEN L. Perrigo Company 9164f7e8-81a0-4b71-a2b3-111b2a7541bb 2023-07-12 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) eaa0a286-a0f0-4979-8af3-c5f4194283fd 2023-06-22 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Rexall Ibuprofen IBUPROFEN Dolgencorp, LLC d2dc2f71-c0cb-4e6d-85b9-fcf386e207a0 2023-06-06 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Proficient Rx LP e4bb22bb-6df6-4016-a023-0b454df9fb0b 2023-06-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN basic care ibuprofen IBUPROFEN Amazon.com Services LLC 3329f487-675d-440c-b7c5-d17a2b024275 2023-05-31 Warnings Name fallback generic name: IBUPROFEN CHILDRENS IBUPROFEN IBUPROFEN BluePoint Laboratories d71acfe2-4643-f50b-e053-2a95a90add8b 2023-05-31 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 7d544d8e-fa76-461f-9417-5f1873912eac 2023-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Equate Ibuprofen IBUPROFEN Wal-Mart Stores Inc 153bc4ac-427d-426a-9bb8-665487e4b169 2023-04-27 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN P & L Development, LLC 1889faea-24a3-45ea-92de-8dc76b9ed5b4 2023-04-25 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN RITE AID CORPORATION de158883-1175-18fc-e053-2995a90a3c96 2023-04-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN MARKSANS PHARMA LIMITED 403ec259-3be1-4e0b-ab7b-fee213b7eabe 2023-04-03 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN Proficient Rx LP 4ee828df-873d-4379-9a17-a805d97dfe04 2023-04-01 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59556-149 Ibuprofen Ibuprofen Strides Pharma Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71682 ORIG 2022-08-01