Home Applications 075217 Application 075217
Type ANDA
Sponsor L PERRIGO CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN SUSPENSION/DROPS;ORAL 40MG/ML 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 A075217-001 IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16
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 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 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 2 of 2 · 31 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 1 of 2 · 89 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0040 Good Sense Infants Ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0057 Good Sense ibuprofen ibuprofen L. Perrigo Company ANDA Current 0363-0057 Ibuprofen ibuprofen Walgreen Company ANDA Current 0363-0057 Ibuprofen ibuprofen Walgreen Company ANDA Current 0363-0255 ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0255 ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-2323 infants dye free ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-2323 infants dye free ibuprofen Ibuprofen Walgreen Company ANDA Current 0904-5463 ibuprofen ibuprofen Major Pharmaceuticals ANDA Current 11673-255 up and up dye free infants concentrated ibuprofen Ibuprofen Target Corporation ANDA Current 11822-0255 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0255 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0255 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0255 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0255 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 21130-363 signature care infants ibuprofen Ibuprofen Safeway ANDA Current 21130-363 signature care infants ibuprofen Ibuprofen Safeway ANDA Current 24385-550 good neighbor pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 30142-057 ibuprofen ibuprofen Kroger Company ANDA Current 30142-057 ibuprofen ibuprofen Kroger Company ANDA Current 30142-255 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-255 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-255 ibuprofen Ibuprofen Kroger Company ANDA Current 36800-057 Topcare Infants Ibuprofen ibuprofen Topco Associates LLC ANDA Current 36800-057 Topcare Infants Ibuprofen ibuprofen Topco Associates LLC ANDA Current 36800-057 Topcare Infants Ibuprofen ibuprofen Topco Associates LLC ANDA Current 36800-255 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-255 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-255 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 37012-255 Infants Ibuprofen Ibuprofen Shopko Stores Operating Co., LLC ANDA Current 37205-436 Leader Ibuprofen Ibuprofen Cardinal Health ANDA Current 37808-057 ibuprofen ibuprofen H E B ANDA Current 37808-255 infants ibuprofen Ibuprofen H E B ANDA Current 37808-255 infants ibuprofen Ibuprofen H E B ANDA Current 41163-057 Equaline Ibuprofen ibuprofen Supervalu Inc ANDA Current 41163-057 Equaline Ibuprofen ibuprofen Supervalu Inc ANDA Current 41163-255 equaline ibuprofen Ibuprofen Supervalu Inc ANDA Current 41163-255 equaline ibuprofen Ibuprofen Supervalu Inc ANDA Current 41190-255 ShopRite Infants Ibuprofen Ibuprofen Wakefern Food Corporation ANDA Current 41190-255 ShopRite Infants Ibuprofen Ibuprofen Wakefern Food Corporation ANDA Current 41250-057 ibuprofen ibuprofen Meijer Distribution Inc ANDA Current 41250-057 ibuprofen ibuprofen Meijer Distribution Inc ANDA Current 41250-255 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41520-057 care one ibuprofen ibuprofen American Sales Company ANDA Current 41520-255 care one ibuprofen Ibuprofen American Sales Company ANDA Current 42507-057 ibuprofen ibuprofen HyVee Inc ANDA Current 42507-255 ibuprofen Ibuprofen HyVee Inc ANDA Current 45802-057 Ibuprofen ibuprofen Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-057 Ibuprofen ibuprofen Perrigo New York Inc ANDA Current 49035-601 parents choice infants ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-601 parents choice infants ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49348-374 sunmark ibuprofen ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-374 sunmark ibuprofen ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-374 sunmark ibuprofen ibuprofen McKesson ANDA Current 49348-642 sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-642 sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-642 sunmark ibuprofen Ibuprofen McKesson ANDA Current 49738-255 smart sense ibuprofen Ibuprofen Kmart Corporation ANDA Current 55316-057 healthy accents ibuprofen ibuprofen DZA Brands LLC ANDA Current 55316-255 healthy accents ibuprofen Ibuprofen DZA Brands LLC ANDA Current 55319-054 kidgets infants ibuprofen Family Dollar Services Inc ANDA Current 55910-057 Health Sense Infants Ibuprofen ibuprofen Dolgencorp Inc ANDA Current 55910-255 dg health ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-255 dg health ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-503 Dg Health Ibuprofen ibuprofen Dolgencorp, LLC ANDA Current 55910-503 Dg Health Ibuprofen ibuprofen Dolgencorp, LLC ANDA Current 56062-057 profen ib ibuprofen Publix Super Markets Inc ANDA Current 56062-255 ibuprofen Ibuprofen Publix Super Markets Inc ANDA Current 56062-404 profen ib Ibuprofen Publix Super Markets Inc ANDA Current 59779-313 ibuprofen Ibuprofen CVS Pharmacy ANDA Current 59779-313 ibuprofen Ibuprofen CVS Pharmacy ANDA Current 59779-995 infants ibuprofen ibuprofen CVS Pharmacy ANDA Current 59779-995 infants ibuprofen ibuprofen CVS Pharmacy ANDA Current 62011-0004 health mart ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 62011-0004 health mart ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 62011-0004 health mart ibuprofen Ibuprofen McKesson ANDA Current 62011-0012 health mart ibuprofen ibuprofen Strategic Sourcing Services LLC ANDA Current 62011-0012 health mart ibuprofen ibuprofen McKesson ANDA Current 62011-0012 health mart ibuprofen ibuprofen Strategic Sourcing Services LLC ANDA Current 64024-255 Welby Infants Ibuprofen Ibuprofen Aldi Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42960 ORIG 1998-12-16 39466 ORIG 1998-12-16 8567 ORIG 1998-12-16