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 16 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN TOPCO ASSOCIATES LLC 1a00c85b-2ba5-32c3-e063-6294a90af148 2025-12-19 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Childrens Ibuprofen Oral Suspension IBUPROFEN Marc Glassman, Inc. 0ef3f4b3-9af5-4243-8d45-dd68f7285229 2025-12-19 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN WALGREENS CO. b8a77b7e-e161-b3ac-e053-2995a90af3e8 2025-12-19 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Childrens Ibuprofen Oral Suspension IBUPROFEN Discount Drug Mart 7b7954b7-e4c8-4284-a649-31a4eb6ba73e 2025-12-19 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Walgreens 07edb8d0-2fa8-4b40-e063-6294a90a2fe9 2025-12-19 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Family Dollar fe17f5a6-fd6d-d839-e053-6394a90a59a4 2025-12-19 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions f24582be-8d70-4848-bd54-e55fa28f394f 2025-12-18 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 463ea713-6b27-b00b-e063-6394a90a8646 2025-12-18 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN BETTER LIVING BRANDS LLC. a3c1a61b-88fc-419c-e053-2a95a90ac0c3 2025-12-18 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN BETTER LIVING BRANDS LLC. 8c3ca03e-0ec2-c15c-e053-2995a90ad8bd 2025-12-18 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions e5db46f3-043b-40ac-a89b-c90bd562e7b4 2025-12-18 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions 3db0c659-cc43-45dc-8442-bc89093d94d7 2025-12-17 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Major Pharmaceuticals 6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6 2025-12-17 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN PD-Rx Pharmaceuticals, Inc. 96bff700-bca3-4b94-b8a2-379102721db8 2025-12-15 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN topcare childrens ibuprofen IBUPROFEN Topco Associates LLC d1bb68a6-3a29-4a4e-b4e9-413cc8d16191 2025-12-12 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN VALU MERCHANDISERS COMPANY 7e2ab4f1-2e87-4fbf-8882-e4d20aef142c 2025-12-11 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN VALU MERCHANDISERS COMPANY a42f96c4-322d-4714-9435-7b5a4e8b6ae5 2025-12-11 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN VALU MERCHANDISERS COMPANY 02e4418a-93ed-2212-e063-6294a90a6c8a 2025-12-11 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN VALU MERCHANDISERS COMPANY 88b3f388-46d3-4e42-98fb-0351c76a15fc 2025-12-11 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN VALU MERCHANDISERS COMPANY 36b95840-f621-437a-bf49-406d320964da 2025-12-11 Warnings 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