Home Applications 079174 Application 079174
Type ANDA
Sponsor GRANULES INDIA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 200MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079174-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2010-12-10
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 2 · 43 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 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 f41ea6bd6efb…
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 1 of 4 · 70 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 3 of 4 · 268 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59726-568 Ibuprofen Ibuprofen P & L Development, LLC ANDA Current 59726-568 Ibuprofen Ibuprofen P & L Development, LLC ANDA Current 59726-568 Ibuprofen Ibuprofen P & L Development, LLC ANDA Current 59726-661 Ibuprofen Ibuprofen P & L Development, LLC ANDA Current 59726-661 Ibuprofen Ibuprofen P & L Development, LLC ANDA Current 59726-661 Ibuprofen Ibuprofen P & L Development, LLC ANDA Current 59726-661 Ibuprofen Ibuprofen P & L Development, LLC ANDA Current 61245-084 Direct Safety Ibuprofen Ibuprofen Conney Safety Products, LLC ANDA Current 61245-084 Direct Safety Ibuprofen Ibuprofen Conney Safety Products, LLC ANDA Current 61245-084 Direct Safety Ibuprofen Ibuprofen Conney Safety Products, LLC ANDA Current 61245-084 Direct Safety Ibuprofen Ibuprofen Conney Safety Products, LLC ANDA Current 61245-084 Direct Safety Ibuprofen Ibuprofen Conney Safety Products, LLC ANDA Current 62207-365 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-365 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-365 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-365 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-365 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-365 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-366 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-366 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-366 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-366 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-366 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-366 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-395 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-395 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-395 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-395 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-395 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-396 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-396 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-396 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-396 Ibuprofen Ibuprofen Granules India Limited ANDA Current 62207-396 Ibuprofen Ibuprofen Granules India Limited ANDA Current 63868-268 Ibuprofen Ibuprofen CHAIN DRUG MARKETING ASSOCIATION INC ANDA Current 63941-109 Ibuprofen Ibuprofen VALU MERCHANDISERS COMPANY ANDA Current 63941-210 Ibuprofen Ibuprofen VALU MERCHANDISERS COMPANY ANDA Current 66715-5507 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-5507 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6707 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6707 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6707 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6707 Circle K Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6839 Lil Drug Store Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6839 Lil Drug Store Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6839 Lil Drug Store Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6920 Lil Drug Store Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6920 Lil Drug Store Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 66715-6920 Lil Drug Store Ibuprofen Ibuprofen Lil Drug Store Products, Inc ANDA Current 67060-001 IBUPROFEN IBUPROFEN 200MG ADVANCED FIRST AID, INC. ANDA Current 67091-347 Ibuprofen Ibuprofen Winco Foods, LLC ANDA Current 67091-348 Ibuprofen Ibuprofen Winco Foods, LLC ANDA Current 68210-0026 Cabinet Pain Reliever and Fever Reducer Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-0026 Cabinet Pain Reliever and Fever Reducer Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-0026 Cabinet Pain Reliever and Fever Reducer Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-0081 Assured Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-0081 Assured Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-4140 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-4140 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-4140 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-4192 Ibuprofen Ibuprofen Spirit Pharmaceuticals LLC ANDA Current 68210-4192 Ibuprofen Ibuprofen Spirit Pharmaceuticals LLC ANDA Current 68210-6114 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-6114 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-8100 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-8100 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-8100 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68210-8100 Ibuprofen Ibuprofen Spirit Pharmaceutical LLC ANDA Current 68599-8051 McKesson Ibuprofen 200 mg Ibuprofen McKesson Medical-Surgical ANDA Current 68599-8051 McKesson Ibuprofen 200 mg Ibuprofen McKesson Medical-Surgical ANDA Current 68599-8051 McKesson Ibuprofen 200 mg Ibuprofen McKesson Medical-Surgical ANDA Current 68998-109 Ibuprofen Ibuprofen Marc Glassman, Inc. ANDA Current 68998-109 Ibuprofen Ibuprofen Marc Glassman, Inc. ANDA Current 68998-110 Ibuprofen Ibuprofen Marc Glassman, Inc. ANDA Current 69168-381 Ibuprofen 200mg Ibuprofen Allegiant Health ANDA Current 69168-381 Ibuprofen 200mg Ibuprofen Allegiant Health ANDA Current 69168-381 Ibuprofen 200mg Ibuprofen Allegiant Health ANDA Current 69168-382 Ibuprofen 200mg Ibuprofen 200mg Allegiant Health ANDA Current 69168-382 Ibuprofen 200mg Ibuprofen 200mg Allegiant Health ANDA Current 69517-111 Fast Pain Relief Ibuprofen HealthLife of USA LLC ANDA Current