Home Applications 214699 Application 214699
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 400MG No No 002 IBUPROFEN IBUPROFEN TABLET;ORAL 600MG No No 003 IBUPROFEN IBUPROFEN TABLET;ORAL 800MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214699-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 A214699-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 A214699-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 3 · 105 observed 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 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214699-002 IBUPROFEN 600MG TABLET / ORAL AB 2021-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214699-003 IBUPROFEN 800MG TABLET / ORAL AB 2021-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214699-001 IBUPROFEN 400MG TABLET / ORAL AB 2021-09-13 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 observed states.
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 31 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dye Free Childrens Ibuprofen IBUPROFEN Precision Dose Inc. eccee4c6-aa94-468a-aebd-265d7a9efb6d 2025-02-12 Warnings Name fallback generic name: IBUPROFEN Equate Ibuprofen IBUPROFEN Wal-Mart Stores Inc 01e9b5b9-cb49-4bfa-9a90-ece8940bf768 2025-02-11 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Brisk Pharmaceuticals 2dcbe4bb-fb24-e827-e063-6394a90acf9f 2025-02-10 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen infants Drops IBUPROFEN Harris Teeter, LLC 2c39a24f-4e42-d75f-e063-6394a90a60fa 2025-02-04 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. fae53f7b-3948-2566-e053-6394a90aae36 2025-02-04 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Harris Teeter, LLC 2bb186c8-f791-5f1f-e063-6294a90a87ff 2025-02-04 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. 0bee69ff-cf76-175e-e063-6294a90a42f6 2025-02-03 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Bi-Mart 7ceacd63-d5fa-4cab-b8f3-a5131c97bb90 2025-02-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN BI-MART 34440532-03e1-4feb-b3e2-dab869edeb15 2025-02-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Dye Free Childrens Ibuprofen IBUPROFEN PAI Holdings, LLC dba PAI Pharma a616a7cd-4814-478e-8c58-7fbc2454d992 2025-01-31 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Padagis Israel Pharmaceuticals Ltd 2457c045-0b7c-48f4-9422-11623f13d8f1 2025-01-29 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN PLD Acquisitions LLC DBA Avma Pharma Solutions c6dcc329-bab5-41ab-94e7-625e07628fd6 2025-01-28 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Advil IBUPROFEN Lil' Drug Store Products, Inc. 772360bd-8631-4d24-b4db-5a7e6e1d9a13 2025-01-27 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Padagis Israel Pharmaceuticals Ltd efb728f2-fe74-4833-8f0c-710d833abf6e 2025-01-27 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN Direct Rx d88d0544-57a7-4a82-e053-2a95a90a1945 2025-01-21 Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Childrens Ibuprofen Oral Suspension, Dye Free IBUPROFEN Best Choice 55fd05c7-b902-4c82-ab9a-8054d880dfbd 2025-01-20 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN DIRECT RX c3f30813-0848-6e8a-e053-2995a90a3dea 2025-01-20 Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Childrens Ibuprofen Oral Suspension, Bubble Gum IBUPROFEN Best Choice d27ca801-d4d3-4fd0-a22b-db5ada5fcb9f 2025-01-20 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen Oral Suspension IBUPROFEN Reliable 1 Laboratories LLC 28dd9baa-43bd-b60a-e063-6394a90a8cf7 2025-01-15 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN PD-Rx Pharmaceuticals, Inc. 7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb 2025-01-13 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.