Home Applications 076359 Application 076359
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET, CHEWABLE;ORAL 50MG No No 002 IBUPROFEN IBUPROFEN TABLET, CHEWABLE;ORAL 100MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076359-001 IBUPROFEN IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 A076359-002 IBUPROFEN IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16
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 3 · 86 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 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 74a2ff9319b5…
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 · 37 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 · 111 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0461 Good Sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0461 Good Sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0788 Basic Care ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-1461 basic care childrens ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-1461 basic care childrens ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-2461 Good Sense Childrens Ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-7619 basic care childrens ibuprofen ibuprofen L. Perrigo Company ANDA Current 0363-0507 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0521 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-0523 Ibuprofen Ibuprofen Walgreen Company ANDA Current 0363-1461 childrens ibuprofen 100 ibuprofen Walgreen Company ANDA Current 0363-1461 childrens ibuprofen 100 ibuprofen Walgreen Company ANDA Current 0363-1521 childrens ibuprofen 100 ibuprofen Walgreen Company ANDA Current 0363-1521 childrens ibuprofen 100 ibuprofen Walgreen Company ANDA Current 11673-461 Up and Up Ibuprofen Ibuprofen Target Corporation ANDA Current 11673-521 up and up junior strength ibuprofen Ibuprofen Target Corporation ANDA Current 11673-593 Up and Up Childrens Ibuprofen ibuprofen Target Corporation ANDA Current 11673-593 Up and Up Childrens Ibuprofen ibuprofen Target Corporation ANDA Current 11673-741 Up and Up Childrens Ibuprofen ibuprofen Target Corporation ANDA Current 11673-741 Up and Up Childrens Ibuprofen ibuprofen Target Corporation ANDA Current 11822-0010 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-0521 ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-1521 childrens ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 11822-4461 Childrens Ibuprofen Ibuprofen Rite Aid Corporation ANDA Current 21130-026 Signature Care Ibuprofen Ibuprofen Safeway ANDA Current 21130-701 signature care childrens ibuprofen ibuprofen Safeway ANDA Current 21130-701 signature care childrens ibuprofen ibuprofen Safeway ANDA Current 24385-546 good neighbor pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 30142-402 childrens ibuprofen ibuprofen Kroger Company ANDA Current 30142-402 childrens ibuprofen ibuprofen Kroger Company ANDA Current 30142-461 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-513 childrens ibuprofen ibuprofen Kroger Company ANDA Current 30142-513 childrens ibuprofen ibuprofen Kroger Company ANDA Current 30142-521 junior strength ibuprofen Ibuprofen Kroger Company ANDA Current 36800-461 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-811 topcare childrens ibuprofen ibuprofen Topco Associates LLC ANDA Current 36800-811 topcare childrens ibuprofen ibuprofen Topco Associates LLC ANDA Current 37012-461 Junior Strength Ibuprofen Ibuprofen Shopko Stores Operating Co., LLC ANDA Current 37012-521 Ibuprofen Ibuprofen Shopko Stores Operating Co., LLC ANDA Current 41163-521 equaline ibuprofen Ibuprofen Supervalu Inc ANDA Current 41163-710 equaline childrens ibuprofen ibuprofen Supervalu Inc ANDA Current 41190-461 ShopRite Ibuprofen IB Ibuprofen Wakefern Food Corporation ANDA Current 41250-331 childrens ibuprofen ibuprofen Meijer Distribution Inc ANDA Current 41250-461 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-461 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-521 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41250-726 childrens ibuprofen ibuprofen Meijer Distribution Inc ANDA Current 41250-726 childrens ibuprofen ibuprofen Meijer Distribution Inc ANDA Current 41520-521 Care One Ibuprofen Ibuprofen American Sales Company ANDA Current 41520-600 Careone ibuprofen junior strength Ibuprofen American Sales Company ANDA Current 41520-633 careone childrens ibuprofen ibuprofen American Sales Company ANDA Current 41520-740 careone childrens ibuprofen ibuprofen American Sales Company ANDA Current 41520-740 careone childrens ibuprofen ibuprofen American Sales Company ANDA Current 41520-933 careone ibuprofen Ibuprofen American Sales Company ANDA Current 41520-933 careone ibuprofen Ibuprofen American Sales Company ANDA Current 46122-010 Good Neighbor Pharmacy Ibuprofen Ibuprofen Amerisource Bergen ANDA Current 46122-010 Good Neighbor Pharmacy Ibuprofen Ibuprofen Amerisource Bergen ANDA Current 46122-617 Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen Amerisource Bergen ANDA Current 46122-617 Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen Amerisource Bergen ANDA Current 46122-632 good neighbor pharmacy childrens ibuprofen Ibuprofen Amerisource Bergen ANDA Current 49035-521 equate ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-521 equate ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-521 equate ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49348-639 Sunmark Ibuprofen IB Ibuprofen McKesson ANDA Current 49348-639 Sunmark Ibuprofen IB Ibuprofen Strategic Sourcing Services LLC ANDA Current 49738-461 smart sense ibuprofen Ibuprofen Kmart Corporation ANDA Current 50580-932 Childrens Motrin Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-932 Childrens Motrin Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-932 Childrens Motrin Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-932 Childrens Motrin Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-933 Childrens Motrin Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-933 Childrens Motrin Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-933 Childrens Motrin Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-933 Childrens Motrin Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 55316-461 Healthy Accents Ibuprofen Ibuprofen DZA Brands LLC ANDA Current 55316-521 healthy accents ibuprofen Ibuprofen DZA Brands LLC ANDA Current 55910-521 rexall ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-521 rexall ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-521 rexall ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 56062-461 ibuprofen Ibuprofen Publix Super Markets Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8900 ORIG 2004-01-22