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 43 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN KROGER COMPANY 3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d 2022-12-27 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION INC. aa91952b-512f-0ead-e053-2995a90a9455 2022-12-21 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Pediacare Childrens Ibuprofen Berry IBUPROFEN RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH 347d081f-068c-4173-9b4b-001ab2b891f5 2022-12-20 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Bionpharma Inc. ba89fbe6-546a-e10c-e053-2a95a90ade0c 2022-12-20 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN INGLES MARKETS, INC. ef536841-768c-919f-e053-2a95a90af599 2022-12-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Walgreens 6bd8a0c2-314f-47cb-80cd-1d4dd92b209f 2022-11-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Concentrated ibuprofen infants IBUPROFEN Guardian Drug Company 3a32f0c7-c03e-4783-a429-08280993ddfb 2022-11-28 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN TOPCO ASSOCIATES LLC cef74c2f-0c23-609d-e053-2a95a90a6b8e 2022-11-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Care One (American Sales Company) 016299ef-ad40-46fd-acfc-e74ffee3d9b4 2022-11-21 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN signature care childrens ibuprofen IBUPROFEN Safeway c30fbb8f-a293-4f6e-9495-11402548fe2d 2022-11-15 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 7f510feb-023c-4974-af6d-3e7a30cef362 2022-11-07 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 8de40427-1be3-4a86-bc4c-9659ebaa203f 2022-11-07 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Proficient Rx LP 9e9fb921-6b6a-422e-95b6-41d6b9047b80 2022-11-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN Kroger Company 3d6ddc2d-d639-4d9d-9a81-a26afdd06eb2 2022-10-26 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN DG Health childrens ibuprofen IBUPROFEN Dolgencorp, LLC 0fd6fcca-cbfe-48af-80dd-2607b5d51b53 2022-10-13 Warnings Name fallback generic name: IBUPROFEN Circle K Ibuprofen IBUPROFEN Lil Drug Store Products, Inc 791a7375-34b2-449b-9284-3c49a2704619 2022-10-11 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN PharmPak, Inc. b493bf76-1e8b-4e72-bef6-aca4efc69cbe 2022-10-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN PharmPak, Inc. 4d95bccd-8280-4d03-a574-927669c7cda0 2022-10-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN PharmPak, Inc. bb6d0547-c113-42f9-8bf2-c227a55ab758 2022-10-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Circle K Ibuprofen IBUPROFEN Lil Drug Store Products, Inc 805d9d80-7de7-49d9-afdb-3a645059fe35 2022-09-21 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