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 24 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Chain Drug Consortium 6c593a9c-680e-4645-8e8f-d8d044c92ca1 2025-07-18 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN topcare childrens ibuprofen IBUPROFEN Topco Associates LLC a88020c0-7982-4307-9836-74de66ea47a5 2025-07-17 Warnings Name fallback generic name: IBUPROFEN profen ib infants IBUPROFEN Publix Super Markets Inc 84aea3fc-4f3b-4a76-a3a6-94ed6549dbea 2025-07-17 Warnings Name fallback generic name: IBUPROFEN childrens ibuprofen IBUPROFEN Meijer Distribution Inc cfe27d2a-b602-4b3e-bdcb-14fed4a236ca 2025-07-17 Warnings Name fallback generic name: IBUPROFEN Dg Health Ibuprofen IBUPROFEN Dolgencorp, LLC 9022e393-084e-499b-ac84-f35360d79592 2025-07-17 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Demoulas Super Markets, Inc 39802e26-1028-d2fe-e063-6394a90a24c7 2025-07-16 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN AMERIFOODS TRADING COMPANY f6dc62db-f728-66fc-e053-6394a90a96b3 2025-07-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN MARC GLASSMAN, INC. 7f366669-9d31-46c7-932d-02fa64b11f30 2025-07-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Marc Glassman, Inc. 9714e804-fadb-103d-e053-2a95a90ad765 2025-07-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN AMERIFOODS TRADING COMPANY f6dc2a73-046b-6b93-e053-6294a90ab295 2025-07-15 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN MARC GLASSMAN, INC. 9714de6b-068b-d6b9-e053-2995a90a3b27 2025-07-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Kroger Company 91da5b64-db7f-4954-89e8-977b31247f9c 2025-07-11 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Rite Aid Corporation 70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d 2025-07-11 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Safeway 0fe94b11-f7c9-4e32-976f-e5f11d01bd64 2025-07-09 Warnings Name fallback generic name: IBUPROFEN Foster and Thrive Ibuprofen IBUPROFEN Strategic Sourcing Services LLC cf330b44-2d69-4f9f-99eb-2caa80aca873 2025-07-08 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Sun Pharmaceutical Industries, Inc. 6cf3328b-da8f-4f6b-8237-16a4d6b9c833 2025-07-07 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Sun Pharmaceutical Industries, Inc. f4dad3d6-1366-4bdf-99eb-370ab74a6b9e 2025-07-07 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Sun Pharmaceutical Industries, Inc. 398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e 2025-07-07 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBU IBUPROFEN Dr. Reddy's Laboratories Limited 24731405-219c-79b4-ecf0-7d5fbfda94ba 2025-07-02 Boxed warning, Warnings, Adverse reactions Name fallback generic name: IBUPROFEN ibuprofen 200 IBUPROFEN Walgreen Company 49a3d51d-55d1-4b80-ab7b-35c27a937cb9 2025-07-02 Warnings Name fallback generic name: IBUPROFEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.