Home Applications 210602 Application 210602
Type ANDA
Sponsor APTAPHARMA INC 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 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 A210602-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23
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 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 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 · 30 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 1 · 49 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-4129 Ibuprofen Oral Ibuprofen Oral A-S Medication Solutions ANDA Current 50090-4129 Ibuprofen Oral Ibuprofen Oral A-S Medication Solutions ANDA Current 50090-4129 Ibuprofen Oral Ibuprofen Oral A-S Medication Solutions ANDA Current 50090-4129 Ibuprofen Oral Ibuprofen Oral A-S Medication Solutions ANDA Current 52412-910 Pediacare Childrens Ibuprofen Berry IBUPROFEN RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH ANDA Current 53942-119 Childrens Ibuprofen Oral Suspension IBUPROFEN DEMOULAS SUPERMARKETS INC. ANDA Current 53943-119 Childrens Ibuprofen Oral Suspension IBUPROFEN Discount Drug Mart ANDA Current 55758-304 Dolex Children Ibuprofen Pharmadel LLC ANDA Current 63629-1230 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-1230 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8540 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8540 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8540 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8851 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8851 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8851 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8852 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8852 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8852 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8853 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8853 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63629-8853 Ibuprofen Oral Ibuprofen Oral Bryant Ranch Prepack ANDA Current 63868-795 Chiidrens Ibuprofen Oral Suspension IBUPROFEN Chain Drug Marketing Association, Inc. ANDA Current 63868-795 Childrens Ibuprofen IBUPROFEN Chain Drug Marketing Association, Inc. ANDA Current 63868-796 Childrens Ibuprofen Oral Suspension IBUPROFEN Chain Drug Marketing Association, Inc. ANDA Current 63868-796 Childrens Ibuprofen Oral Suspension IBUPROFEN Chain Drug Marketing Association, Inc. ANDA Current 67091-367 WinCo Foods Childrens Ibuprofen Childrens Ibuprofen Oral Suspension WinCo Foods, LLC ANDA Current 68071-1628 Ibuprofen Oral Ibuprofen Oral NuCare Pharmaceuticals,Inc. ANDA Current 68071-1628 Ibuprofen Oral Ibuprofen Oral NuCare Pharmaceuticals,Inc. ANDA Current 68788-7984 Ibuprofen Oral Ibuprofen Oral Preferred Pharmaceuticals Inc. ANDA Current 68788-7984 Ibuprofen Oral Ibuprofen Oral Preferred Pharmaceuticals Inc. ANDA Current 68998-320 Childrens Ibuprofen Oral Suspension Ibuprofen Marc Glassman, Inc. ANDA Current 69230-308 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care ANDA Current 69230-308 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care ANDA Current 69230-308 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care Inc ANDA Current 69230-309 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care ANDA Current 69230-309 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care Inc ANDA Current 69230-310 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care ANDA Current 69230-310 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care Inc ANDA Current 69230-311 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care ANDA Current 69230-311 Ibuprofen Oral Ibuprofen Oral Camber Consumer Care Inc ANDA Current 70677-0150 Ibuprofen Oral Ibuprofen Oral Strategic Sourcing Services ANDA Current 70677-0151 Ibuprofen Oral Ibuprofen Oral Strategic Sourcing Services ANDA Current 70677-0152 Ibuprofen Oral Ibuprofen Oral Strategic Sourcing Services ANDA Current 70677-0153 Ibuprofen Oral Ibuprofen Oral Strategic Sourcing Services ANDA Current 76281-119 Childrens Ibuprofen Oral Suspension IBUPROFEN AptaPharma Inc. ANDA Current 76281-119 Childrens Ibuprofen Oral Suspension IBUPROFEN AptaPharma Inc. ANDA Current 82179-001 KOSHER MEDS Ibuprofen Mollec Inc ANDA Current 82179-001 KOSHER MEDS Ibuprofen Mollec Inc ANDA Current