Home Applications 076112 Application 076112
Type ANDA
Sponsor DR REDDYS LABS INC 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 No
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 A076112-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 A076112-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 A076112-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31
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 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076112-002 IBUPROFEN 600MG TABLET / ORAL AB 2001-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076112-003 IBUPROFEN 800MG TABLET / ORAL AB 2001-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076112-001 IBUPROFEN 400MG TABLET / ORAL AB 2001-10-31 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 14 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN HYVEE INC 459fc670-32a3-61a6-e063-6294a90aea5a 2026-01-13 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN L.N.K. International, Inc. 8ebe3e16-b7ae-d333-6671-5bc935e25900 2026-01-13 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN HyVee Inc 2fd51545-1d1f-4b2e-a084-d28ba223e720 2026-01-13 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN ibuprofen infants IBUPROFEN HyVee Inc e8fcaf17-234a-4d64-b621-9ca505884b0a 2026-01-12 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN L.N.K. International, Inc. d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c 2026-01-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Meijer Distribution Inc c0c64ba5-b6b0-4221-9e44-110d92c93782 2026-01-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Coupler LLC 4831785a-cde2-79a2-e063-6294a90a9a40 2026-01-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN L.N.K. International, Inc. c93da67f-f42e-4baa-976b-73c71ba6dd71 2026-01-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN GOOD SENSE CHILDRENS IBUPROFEN IBUPROFEN L. Perrigo Company cd06ffc5-4921-4b2d-88ea-939fa4daf59c 2026-01-09 Warnings Name fallback generic name: IBUPROFEN Xpect Ibuprofen IBUPROFEN Cintas Corporation 976ba88a-6428-40d1-a2fd-eac64963ba1d 2026-01-08 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN Strides Pharma Inc 69b208ff-83f5-40d1-a2ff-d54b390e46e4 2026-01-08 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN ibuprofen IBUPROFEN CVS Pharmacy ace493e6-91bc-41aa-8e5c-5bc14981de91 2026-01-06 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Ibuprofen minis IBUPROFEN Safeway, Inc. 22927a12-6837-4d57-8e60-043000f2f208 2026-01-05 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN DOLGENCORP, LLC 37ccb303-c70e-48b3-a8a3-2b0097cf8f88 2026-01-05 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN DG Health Ibuprofen IBUPROFEN Dolgencorp Inc 1dd4ffc5-3132-419b-8e70-78a7bb71da62 2026-01-02 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC 2f12a20c-4293-d18a-e063-6294a90a3afc 2026-01-02 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC c20f1f4d-59b3-6bbe-e053-2a95a90abaf1 2026-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC ab313564-27dc-0297-e053-2a95a90a6690 2026-01-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC dac07d8f-6b6f-20ab-e053-2a95a90af3ba 2026-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC da6c72ad-009f-3d7f-e053-2995a90a68e9 2026-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49999-042 IBU Ibuprofen Lake Erie Medical DBA Quality Care Products LLC ANDA Current 49999-042 IBU Ibuprofen Lake Erie Medical DBA Quality Care Products LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43052 ORIG 2001-10-31