Home Applications 074937 Application 074937
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CHILDREN'S IBUPROFEN IBUPROFEN SUSPENSION;ORAL 100MG/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A074937-001 CHILDREN'S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22
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 · 44 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 2026-10-15 13:18:30 2026-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3a93d1ddd44b…
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 4 · 79 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 2 of 3 · 233 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 37808-897 rx act ibuprofen Ibuprofen H E B ANDA Current 37808-897 rx act ibuprofen Ibuprofen H E B ANDA Current 41163-166 Equaline ibuprofen Ibuprofen Supervalu Inc ANDA Current 41163-685 Equaline Ibuprofen Ibuprofen Supervalu Inc ANDA Current 41163-897 equaline ibuprofen Ibuprofen Supervalu Inc ANDA Current 41190-166 ShopRite Childrens Ibuprofen Ibuprofen Wakefern Food Corporation ANDA Current 41190-660 ShopRite Childrens Ibuprofen Ibuprofen Wakefern Food Corporation ANDA Current 41190-660 ShopRite Childrens Ibuprofen Ibuprofen Wakefern Food Corporation ANDA Current 41190-897 ShopRite Ibuprofen Ibuprofen Wakefern Food Corporation ANDA Current 41250-240 childrens ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-240 childrens ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-419 Childrens Ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-419 Childrens Ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-626 childrens ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-626 childrens ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-660 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-660 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-660 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-685 childrens ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-685 childrens ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-897 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-897 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-911 childrens ibuprofen oral suspension Ibuprofen Meijer Distribution Inc ANDA Current 41520-166 care one ibuprofen Ibuprofen American Sales Company ANDA Current 41520-166 care one ibuprofen Ibuprofen American Sales Company ANDA Current 41520-660 care one ibuprofen Ibuprofen American Sales Company ANDA Current 41520-685 Care One ibuprofen Ibuprofen American Sales Company ANDA Current 41520-897 care one ibuprofen Ibuprofen American Sales Company ANDA Current 42254-117 good sense ibuprofen Ibuprofen Rebel Distributors Corp ANDA Current 42507-166 ibuprofen Ibuprofen HyVee Inc ANDA Current 42507-660 Ibuprofen Ibuprofen HyVee Inc ANDA Current 42507-685 Ibuprofen Ibuprofen HyVee Inc ANDA Current 42507-685 Ibuprofen Ibuprofen HyVee Inc ANDA Current 42507-897 ibuprofen Ibuprofen HyVee Inc ANDA Current 45802-133 Childrens Ibuprofen Ibuprofen Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-133 Childrens Ibuprofen Ibuprofen Perrigo New York Inc ANDA Current 45802-140 Childrens Ibuprofen Ibuprofen Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-140 Childrens Ibuprofen Ibuprofen Perrigo New York Inc ANDA Current 45802-897 ibuprofen Ibuprofen Perrigo New York Inc ANDA Current 45802-897 ibuprofen Ibuprofen Padagis Israel Pharmaceuticals Ltd ANDA Current 46122-110 good neighbor pharmacy childrens ibuprofen Ibuprofen Amerisource Bergen ANDA Current 46994-897 being well ibuprofen Ibuprofen Save-A-Lot Food Stores Ltd ANDA Current 46994-897 being well ibuprofen Ibuprofen Save-A-Lot Food Stores Ltd ANDA Current 46994-897 being well ibuprofen Ibuprofen Save-A-Lot Food Stores Ltd ANDA Current 49035-166 equate ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-660 equate ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-897 equate ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49348-229 sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-229 sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-229 sunmark ibuprofen Ibuprofen McKesson ANDA Current 49348-499 Sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-499 Sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-499 Sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-499 Sunmark ibuprofen Ibuprofen McKesson ANDA Current 49348-500 Sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-500 Sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-500 Sunmark ibuprofen Ibuprofen McKesson ANDA Current 49348-876 Sunmark ibuprofen Ibuprofen McKesson ANDA Current 49348-876 Sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-876 Sunmark ibuprofen Ibuprofen Strategic Sourcing Services LLC ANDA Current 49738-166 Smart Sense ibuprofen Ibuprofen Kmart Corporation ANDA Current 49738-685 Smart Sense ibuprofen Ibuprofen Kmart Corporation ANDA Current 49738-897 smart sense ibuprofen Ibuprofen Kmart Corporation ANDA Current 50090-3227 CHILDRENS IBUPROFEN Ibuprofen A-S Medication Solutions ANDA Current 50090-3408 Ibuprofen Ibuprofen A-S Medication Solutions ANDA Current 50090-3408 Ibuprofen Ibuprofen A-S Medication Solutions ANDA Current 50594-018 Sound Body Childrens Ibuprofen Ibuprofen Big Lots Stores, Inc. ANDA Current 52959-298 Ibuprofen Ibuprofen H.J. Harkins Company, Inc. ANDA Current 55154-1577 Childrens Ibuprofen Ibuprofen Cardinal Health 107, LLC ANDA Current 55154-1577 Childrens Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-1585 Childrens Ibuprofen Ibuprofen Cardinal Health ANDA Current 55312-685 childrens ibuprofen Ibuprofen Western Family Foods Inc ANDA Current 55316-166 Healthy Accents ibuprofen Ibuprofen DZA Brands LLC ANDA Current 55316-897 healthy accents ibuprofen Ibuprofen DZA Brands LLC ANDA Current 55319-166 family wellness childrens ibuprofen Ibuprofen Family Dollar Services Inc ANDA Current 55319-166 family wellness childrens ibuprofen Ibuprofen Family Dollar Services Inc ANDA Current 55319-166 family wellness childrens ibuprofen Ibuprofen Family Dollar Services Inc ANDA Current 55319-897 family wellness childrens ibuprofen Ibuprofen Family Dollar Services Inc ANDA Current 55319-897 family wellness childrens ibuprofen Ibuprofen Family Dollar Services Inc ANDA Current 55910-102 dg health childrens ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39446 ORIG 1998-12-22 22386 ORIG 1998-12-22 8469 ORIG 1998-12-22