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 43 .
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 · 129 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 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075682-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075682-003 IBUPROFEN 800MG TABLET / ORAL AB RS 2001-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075682-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-11-14 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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
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 3 · 185 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-8115 IBU Ibuprofen NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8115 IBU Ibuprofen NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8116 IBU Ibuprofen NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8116 IBU Ibuprofen NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8117 IBU Ibuprofen NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8117 IBU Ibuprofen NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0904-5853 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 0904-5853 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 0904-5854 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 0904-5854 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 0904-5855 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 0904-5855 Ibuprofen Ibuprofen Major Pharmaceuticals ANDA Current 10544-071 IBU Ibuprofen Blenheim Pharmacal, Inc. ANDA Current 10544-625 IBU Ibuprofen Blenheim Pharmacal, Inc. ANDA Current 12634-171 IBUPROFEN Ibuprofen Apotheca Inc. ANDA Current 12634-191 IBUPROFEN Ibuprofen Apotheca Inc. ANDA Current 12634-682 IBUPROFEN Ibuprofen Apotheca Inc. ANDA Current 21695-066 Ibuprofen Ibuprofen Rebel Distributors Corp ANDA Current 21695-067 Ibuprofen Ibuprofen Rebel Distributors Corp ANDA Current 21695-068 Ibuprofen Ibuprofen Rebel Distributors Corp ANDA Current 35356-699 IBU Ibuprofen Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-699 IBU Ibuprofen Lake Erie Medical DBA Quality Care Products LLC ANDA Current 43353-095 Ibuprofen Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-095 Ibuprofen Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-273 IBU Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-314 Ibuprofen Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-314 Ibuprofen Ibuprofen Aphena Pharma Solutions - Tennessee, LLC ANDA Current 50090-4331 IBU Ibuprofen A-S Medication Solutions ANDA Current 50090-4333 IBU Ibuprofen A-S Medication Solutions ANDA Current 50090-4339 IBU Ibuprofen A-S Medication Solutions ANDA Current 50090-4341 IBU Ibuprofen A-S Medication Solutions ANDA Current 50436-0684 IBU Ibuprofen Unit Dose Services ANDA Current 50436-4604 IBU Ibuprofen Unit Dose Services ANDA Current 50436-4605 IBU Ibuprofen Unit Dose Services ANDA Current 51407-369 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 51407-370 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 51407-371 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 51655-851 Ibuprofen Ibuprofen Northwind Pharmaceuticals ANDA Current 53002-3010 IBU Ibuprofen RPK Pharmaceuticals, Inc. ANDA Current 53002-3010 IBU Ibuprofen RPK Pharmaceuticals, Inc. ANDA Current 53002-3370 IBU Ibuprofen RPK Pharmaceuticals, Inc. ANDA Current 53002-3370 IBU Ibuprofen RPK Pharmaceuticals, Inc. ANDA Current 53002-3980 IBU Ibuprofen RPK Pharmaceuticals, Inc. ANDA Current 53002-3980 IBU Ibuprofen RPK Pharmaceuticals, Inc. ANDA Current 53217-366 IBU Ibuprofen Aidarex Pharmaceuticals LLC ANDA Current 55111-682 IBU Ibuprofen Dr. Reddy's Laboratories Limited ANDA Current 55111-682 IBU Ibuprofen Dr. Reddy's Laboratories Limited ANDA Current 55111-683 IBU Ibuprofen Dr. Reddy's Laboratories Limited ANDA Current 55111-683 IBU Ibuprofen Dr. Reddy's Laboratories Limited ANDA Current 55111-684 IBU Ibuprofen Dr. Reddy's Laboratories Limited ANDA Current 55111-684 IBU Ibuprofen Dr. Reddy's Laboratories Limited ANDA Current 55154-0741 Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-0741 Ibuprofen Ibuprofen Cardinal Health 107, LLC ANDA Current 55154-0741 Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-0741 Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-1342 Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-1342 Ibuprofen Ibuprofen Cardinal Health 107, LLC ANDA Current 55154-1342 Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-1342 Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-1380 Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-1380 Ibuprofen Ibuprofen Cardinal Health 107, LLC ANDA Current 55154-1380 Ibuprofen Ibuprofen Cardinal Health ANDA Current 55154-1380 Ibuprofen Ibuprofen Cardinal Health ANDA Current 59088-703 PharmapureRx IBU 600-EZS ibuprofen PureTek Corporation ANDA Current 60429-219 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 60429-219 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 60429-220 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 60429-220 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 60429-221 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 60429-221 IBU Ibuprofen Golden State Medical Supply, Inc. ANDA Current 60760-076 IBU Ibuprofen St. Mary's Medical Park Pharmacy ANDA Current 60760-076 IBU Ibuprofen St. Mary's Medical Park Pharmacy ANDA Current 60760-135 IBU Ibuprofen St. Mary ANDA Current 61919-621 IBU IBU DirectRX ANDA Current 61919-621 IBU IBU DIRECT RX ANDA Current 61919-621 IBU IBU DirectRX ANDA Current 61919-621 IBU IBU DirectRX ANDA Current 61919-621 IBU IBU Direct_Rx ANDA Current 61919-621 IBU IBU Direct_Rx ANDA Current 61919-621 IBU IBU Direct_Rx ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22495 ORIG 2005-07-22 8763 ORIG 2003-04-14