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 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 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 · 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 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…2022-10-28 04:53 UTC 2022-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 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 5 · 82 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 3 · 233 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0166 good sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0166 good sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0660 Good Sense Ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0685 Good Sense Ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0897 good sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-7660 basic care childrens ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-7897 Basic Care childrens ibuprofen Ibuprofen L Perrigo Company ANDA Current 0121-1836 Childrens Ibuprofen Ibuprofen Pharmaceutical Associates, Inc. ANDA Current 0363-0040 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0166 ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0166 ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0660 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0660 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0660 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0685 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0806 Childrens Ibuprofen 100 Ibuprofen Walgreen Company ANDA Current 0363-0806 Childrens Ibuprofen 100 Ibuprofen Walgreen Company ANDA Current 0363-0806 Childrens Ibuprofen 100 Ibuprofen Walgreen Company ANDA Current 0363-0897 ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0897 ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0897 ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-1501 Childrens Ibuprofen 100 Ibuprofen Walgreen Company ANDA Current 0904-5309 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 0904-5309 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 0904-5577 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 10202-897 7 Select Childrens Ibuprofen Ibuprofen 7-Eleven ANDA Current 10202-897 7 Select Childrens Ibuprofen Ibuprofen 7-Eleven ANDA Current 11673-166 Up and Up childrens ibuprofen Ibuprofen Target Corporation ANDA Current 11673-660 up and up childrens ibuprofen Ibuprofen Target Corporation ANDA Current 11673-685 up and up ibuprofen Ibuprofen Target Corporation ANDA Current 11822-0166 Childrens Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0660 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0897 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 17856-5309 Ibuprofen Ibuprofen Atlantic Biologicals Corps ANDA Current 17856-5309 Ibuprofen Ibuprofen Atlantic Biologicals Corps ANDA Current 17856-5309 Ibuprofen Ibuprofen Atlantic Biologicals Corps ANDA Current 21130-011 signature care childrens ibuprofen Ibuprofen Safeway ANDA Current 21130-035 Signature Care Childrens Ibuprofen Ibuprofen Safeway ANDA Current 21130-606 signature care ibuprofen Ibuprofen Safeway ANDA Current 21130-911 signature care childrens ibuprofen Ibuprofen Safeway ANDA Current 24385-009 Good Neighbor Pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 24385-361 Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen Amerisource Bergen ANDA Current 24385-372 Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen Amerisource Bergen ANDA Current 24385-905 good neighbor pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 30142-166 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-166 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-166 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-660 Ibuprofen Ibuprofen Kroger Company ANDA Current 30142-660 Ibuprofen Ibuprofen Kroger Company ANDA Current 30142-660 Ibuprofen Ibuprofen Kroger Company ANDA Current 30142-685 Ibuprofen Ibuprofen Kroger Company ANDA Current 30142-685 Ibuprofen Ibuprofen Kroger Company ANDA Current 30142-685 Ibuprofen Ibuprofen Kroger Company ANDA Current 30142-897 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-897 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-897 ibuprofen Ibuprofen Kroger Company ANDA Current 36800-166 topcare childrens ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-166 topcare childrens ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-166 topcare childrens ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-166 topcare childrens ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-660 Topcare Childrens Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-660 Topcare Childrens Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-660 Topcare Childrens Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-660 Topcare Childrens Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-660 Topcare Childrens Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-685 Topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-685 Topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-685 Topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-685 Topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-897 topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-897 topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-897 topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 37012-166 childrens ibuprofen Ibuprofen Shopko Stores Operating Co., LLC ANDA Current 37012-685 Childrens Ibuprofen Ibuprofen Shopko Stores Operating Co., LLC ANDA Current 37012-897 Childrens Ibuprofen Ibuprofen Shopko Stores Operating Co., LLC ANDA Current 37808-023 ibuprofen Ibuprofen H E B ANDA Current 37808-023 ibuprofen Ibuprofen H E B ANDA Current 37808-200 childrens ibuprofen Ibuprofen H E B ANDA Current 37808-200 childrens ibuprofen Ibuprofen H E B ANDA Current 37808-363 Ibuprofen Ibuprofen H E B 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