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 22 of 48 · 948 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.