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 27 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join up and up childrens ibuprofen IBUPROFEN Target Corporation 834b7f5e-e636-4537-9bae-2d309fcc8eb3 2025-06-02 Warnings Name fallback generic name: IBUPROFEN equate ibuprofen childrens IBUPROFEN Wal-Mart Stores Inc ed9ee7b5-2d9a-4aaf-a245-aa13fcc6365a 2025-05-23 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Bryant Ranch Prepack 92878aad-0bf9-4303-a1f8-4b9b23848a71 2025-05-21 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 2c3f8149-9b77-54cd-e063-6394a90a847e 2025-05-21 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN childrens ibuprofen IBUPROFEN CVS Pharmacy 884d51d8-4774-4dde-b854-32abfb4b712d 2025-05-20 Warnings Name fallback generic name: IBUPROFEN Ibuprofen minis IBUPROFEN P & L Development, LLC 18b79fc5-57c8-46f1-81f3-2f9e189cdbcb 2025-05-16 Warnings Name fallback generic name: IBUPROFEN dg health ibuprofen IBUPROFEN Dolgencorp, LLC d6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f59 2025-05-15 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION, INC. a60a6301-60b7-4f31-9ebe-872ccd8e9e76 2025-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION, INC. 32f86bfb-67a6-49b5-a90a-5197f0d1baba 2025-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN DISCOUNT DRUG MART 9998b851-825b-a97d-e053-2a95a90affc6 2025-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN DISCOUNT DRUG MART 999902da-4850-68ab-e053-2a95a90a82ea 2025-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 3520deb7-5e45-3d0f-e063-6394a90ab44b 2025-05-14 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN profen ib IBUPROFEN Publix Super Markets Inc 51fbfd25-3c4d-4de1-8fa2-e5b4b24022f2 2025-05-13 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN ATLANTIC BIOLOGICALS CORP. 230914e6-fe0c-45be-8b2e-e066c71d004c 2025-05-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN good sense ibuprofen childrens IBUPROFEN L. Perrigo Company b8e3ad4f-3212-4674-bcdf-a60a6b23d7bb 2025-05-12 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Meijer Distribution Inc 3b15dc44-ae1d-43c6-b6c5-05fa31beb554 2025-05-12 Warnings Name fallback generic name: IBUPROFEN Up and Up childrens ibuprofen IBUPROFEN Target Corporation 28911692-882b-4e30-ba1d-5c10f847be80 2025-05-12 Warnings Name fallback generic name: IBUPROFEN Equaline Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI c611afc0-5cde-4f01-908a-de52cb61ab02 2025-05-08 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN AAFES/Your Military Exchanges 773b0230-a3a3-44e0-a22b-d143796ca365 2025-05-08 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Equaline ibuprofen childrens IBUPROFEN United Natural Foods, Inc. dba UNFI 811d4360-7468-4ef8-a60e-6e9a6e169de0 2025-05-08 Warnings Name fallback 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