Home Applications 075682 Application 075682
Type ANDA
Sponsor DR REDDYS LA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 400MG No No 002 IBUPROFEN IBUPROFEN TABLET;ORAL 600MG No No 003 IBUPROFEN IBUPROFEN TABLET;ORAL 800MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075682-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 A075682-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 A075682-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 132 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 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IBU IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC ffec2f44-1144-4729-b43a-1db40ea6a8d3 2019-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075682 application number: ANDA075682 ndc (product): 71610-275
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 3 of 3 · 185 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68788-9112 Ibuprofen Ibuprofen Preferred Pharmaceuticals, Inc. ANDA Current 68788-9112 Ibuprofen Ibuprofen Preferred Pharmaceuticals, Inc. ANDA Current 68788-9112 Ibuprofen Ibuprofen Preferred Pharmaceuticals, Inc. ANDA Current 69176-035 Toxicology Saliva Collection Kit Toxicology Saliva Collection Kit TMIG, Inc. ANDA Current 70518-0146 Ibuprofen Ibuprofen REMEDYREPACK INC. ANDA Current 70518-0490 IBU Ibuprofen REMEDYREPACK INC. ANDA Current 70518-0490 IBU Ibuprofen REMEDYREPACK INC. ANDA Current 70518-0969 Ibuprofen Ibuprofen REMEDYREPACK INC. ANDA Current 70518-0969 Ibuprofen Ibuprofen REMEDYREPACK INC. ANDA Current 70518-1145 IBU Ibuprofen REMEDYREPACK INC. ANDA Current 70518-1145 IBU Ibuprofen REMEDYREPACK INC. ANDA Current 70518-2440 IBU Ibuprofen REMEDYREPACK INC. ANDA Current 70859-030 NuDroxiPAK I-800 Ibuprofen,Methyl Salicylate/Menthol/Capsaicin NuCare Pharmaceuticals,Inc. ANDA Current 70859-030 NuDroxiPAK I-800 Ibuprofen,Methyl Salicylate/Menthol/Capsaicin NuCare Pharmaceuticals,Inc. ANDA Current 70934-195 IBU Ibuprofen Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-195 IBU Ibuprofen Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 71205-604 IBU Ibuprofen Proficient Rx LP ANDA Current 71205-604 IBU Ibuprofen Proficient Rx LP ANDA Current 71610-275 IBU Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71610-414 Ibuprofen Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71610-414 Ibuprofen Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71610-414 Ibuprofen Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71610-501 IBU Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71610-547 IBU Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71610-550 IBU Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22495 ORIG 2005-07-22 8763 ORIG 2003-04-14