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 29 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DG Health Ibuprofen IBUPROFEN Dolgencorp Inc 0c0cf516-b3e7-474d-885c-897574365be3 2025-04-28 Warnings Name fallback generic name: IBUPROFEN ibuprofen childrens IBUPROFEN Meijer Distribution Inc c5e1d74d-99a3-4b3d-86c4-03f5c4c22f77 2025-04-27 Warnings Name fallback generic name: IBUPROFEN kirkland signature ibuprofen IBUPROFEN Costco Wholesale Company 65d8d650-9afc-44f7-9409-a3aa3014d4ab 2025-04-24 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN A-S Medication Solutions 504c7e5d-e721-4df8-865b-8ea17559831d 2025-04-24 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 334e40f3-6da4-ecbe-e063-6294a90a35bf 2025-04-21 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Equaline Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 5e860059-afc8-419e-9451-b1c2265f5ce6 2025-04-18 Warnings Name fallback generic name: IBUPROFEN Leader Ibuprofen IBUPROFEN Cardinal Health 110, LLC. dba Leader a5701486-0a5f-4645-91ef-1fbf525c84dd 2025-04-18 Warnings Name fallback generic name: IBUPROFEN childrens ibuprofen IBUPROFEN Meijer Distribution Inc 02681a10-eb8a-457f-8aff-12e6f29079de 2025-04-18 Warnings Name fallback generic name: IBUPROFEN Good Neighbor Pharmacy ibuprofen childrens IBUPROFEN Amerisource Bergen 43b8e61b-3ac4-4a41-b682-67d08b212cc6 2025-04-18 Warnings Name fallback generic name: IBUPROFEN Good Sense Ibuprofen IBUPROFEN L. Perrigo Company 1a6b42be-c0c2-48f8-9ba3-22d1f0c0b18d 2025-04-18 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Allegiant Health 2ea039d6-f522-4103-a1f9-5b80a3b12a27 2025-04-14 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN up and up ibuprofen IBUPROFEN Target Corporation 2919fe8b-9c76-4ef6-851e-3247782cef44 2025-04-11 Warnings Name fallback generic name: IBUPROFEN equaline ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI e18f4ce6-d7d3-4b53-b87a-5900ac3397f1 2025-04-11 Warnings Name fallback generic name: IBUPROFEN TopCare Ibuprofen IBUPROFEN Topco Associates LLC 66097f19-227c-4f9c-a7f3-ab8476e1bb6e 2025-04-08 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Major Pharmaceuticals 14f43c32-0895-4ef2-aa54-52b952d058fd 2025-04-08 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN parents choice infants ibuprofen IBUPROFEN Wal-Mart Stores Inc a826d6cc-f582-4508-897d-0d637de0666c 2025-04-07 Warnings Name fallback generic name: IBUPROFEN up and up dye free infants concentrated ibuprofen IBUPROFEN Target Corporation 6cfdcd94-95cb-4447-a14b-cdb49a1e3114 2025-04-07 Warnings Name fallback generic name: IBUPROFEN leader infants ibuprofen IBUPROFEN Cardinal Health 110, LLC. dba Leader b72fdf65-8112-4d8b-b86f-8e17a40ee8e6 2025-04-07 Warnings Name fallback generic name: IBUPROFEN equaline ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI ea2ba726-0199-42ae-9c60-4b068df35e64 2025-04-07 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 31f59d10-d821-2291-e063-6294a90ac518 2025-04-04 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.