Home Applications 209179 Application 209179
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN SUSPENSION;ORAL 100MG/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A209179-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 cb3db0bc1861…
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 1 · 12 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10202-150 CHILDRENS IBUPROFEN Ibuprofen 7-Eleven ANDA Current 10202-711 CHILDRENS IBUPROFEN Ibuprofen 7-Eleven ANDA Current 10202-711 CHILDRENS IBUPROFEN Ibuprofen 7-Eleven ANDA Current 10202-711 CHILDRENS IBUPROFEN Ibuprofen 7-Eleven ANDA Current 10202-711 CHILDRENS IBUPROFEN Ibuprofen 7-Eleven ANDA Current 58602-002 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-002 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-003 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-008 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-200 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-200 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-200 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-200 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-200 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-212 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-212 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-212 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 58602-212 CHILDRENS IBUPROFEN Ibuprofen Aurohealth LLC ANDA Current 68001-435 CHILDRENS IBUPROFEN Ibuprofen BluePoint Laboratories ANDA Current 68001-435 CHILDRENS IBUPROFEN Ibuprofen BluePoint Laboratories ANDA Current 68001-521 CHILDRENS IBUPROFEN Ibuprofen BluePoint Laboratories ANDA Current 79395-003 CHILDRENS IBUPROFEN Ibuprofen Chalkboard Health ANDA Current 79395-003 CHILDRENS IBUPROFEN Ibuprofen Chalkboard Health ANDA Current 79395-003 CHILDRENS IBUPROFEN Ibuprofen Chalkboard Health ANDA Current