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 19 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join childrens ibuprofen IBUPROFEN Kroger Company 96c955b1-3139-4b12-b584-83804bc1ca6b 2025-11-03 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. f60445d3-807e-0bbf-e053-2995a90a1299 2025-10-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN KOSHER MEDS IBUPROFEN Mollec Inc c9c31326-6a19-9a9c-e053-2a95a90aed06 2025-10-29 Warnings Name fallback generic name: IBUPROFEN Kosher Meds Dye-Free Ibuprofen IBUPROFEN Mollec Inc ba1a0bc2-0a28-4d73-9667-5a220b806e87 2025-10-29 Warnings Name fallback generic name: IBUPROFEN Up and Up Childrens Ibuprofen IBUPROFEN Target Corporation 17b3ca97-1bd6-4e76-a47f-2e35ef36b707 2025-10-28 Warnings Name fallback generic name: IBUPROFEN childrens ibuprofen 100 IBUPROFEN Walgreen Company 7b798146-393f-422c-87f0-0bf800df0c71 2025-10-28 Warnings Name fallback generic name: IBUPROFEN careone childrens ibuprofen IBUPROFEN American Sales Company bca90b40-7973-4f22-8647-44cce5a6036e 2025-10-28 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions 8d5f7d2a-af48-4d47-8bf5-48f01c092d24 2025-10-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions 4b75bd6f-5455-4237-991c-eacc0fdcf709 2025-10-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN childrens ibuprofen 100 IBUPROFEN Walgreen Company 9b748f51-1d09-46ca-9dba-fec226c027e0 2025-10-26 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN CVS Pharmacy 93f8101c-1cf7-4cb0-9c00-c57c9f9023c8 2025-10-26 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Up and Up Childrens Ibuprofen IBUPROFEN Target Corporation eead7d57-dfd3-4007-a620-74afebc3d365 2025-10-26 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) 3a02af7e-7e69-45a6-97d7-ddc7d92b28b3 2025-10-22 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Foster and Thrive Ibuprofen IBUPROFEN Strategic Sourcing Services LLC bcfa45ac-63d6-49a7-aa1c-b9f1d6c571f3 2025-10-22 Warnings Name fallback generic name: IBUPROFEN Ibuprofen Minis IBUPROFEN Family Dollar (FAMILY WELLNESS) 72f933d8-cf01-4bb6-a552-e3cdb297038b 2025-10-21 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Advanced Rx of Tennessee, LLC 41351cc0-5ec6-2f4d-e063-6294a90a733a 2025-10-15 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN childrens ibuprofen IBUPROFEN Safeway 6dbf5acc-46a1-4d5b-a9a6-9b77f106d711 2025-10-14 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Direct_rx 1be33b4f-4987-580f-e063-6294a90a3103 2025-10-13 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Coupler LLC 410f7320-4caa-8f88-e063-6394a90acf93 2025-10-13 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Preferred Pharmaceuticals Inc. a85080d7-50b4-461b-9d77-d6fbab971c03 2025-10-13 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.