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 6 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN CAPSULE PUBLIX SUPER MARKETS INC 10a6eba7-e400-ce97-e063-6294a90af3bd 2026-06-23 Warnings Name fallback brand name: Ibuprofen IBUPROFEN IBUPROFEN DISCOUNT DRUG MART, INC. d07ea9e3-88b0-4aa0-903a-10555dcca37d 2026-06-23 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN DISCOUNT DRUG MART, INC. aae40114-343e-12da-e053-2a95a90a9213 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN BJWC 0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN pain relief IBUPROFEN Bionpharma Inc. 2b4ecdd8-627a-445f-8ddc-f2b6c832c1e8 2026-06-23 Warnings Name fallback generic name: IBUPROFEN dye-free pain relief IBUPROFEN Bionpharma Inc. c46c9c36-8844-7b50-e053-2a95a90aa0e9 2026-06-23 Warnings Name fallback generic name: IBUPROFEN dye-free pain relief IBUPROFEN Bionpharma Inc. 4227d0b7-846a-dcb0-e063-6294a90af7d7 2026-06-23 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION INC. 3c1c1b65-f57f-62b0-e063-6294a90a1021 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Chain Drug Marketing Association, Inc. 3802982a-2373-9ca3-e063-6394a90a0ab7 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN CHAIN DRUG MARKETING ASSOCIATION INC. 4573753d-117b-a6f2-e063-6394a90ae2f9 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Chain Drug Marketing Association, Inc. 3ed7faff-fd48-0a83-e063-6394a90aab14 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Pain Relief IBUPROFEN Albertsons Companies f9deaeb7-efb3-4019-e053-6394a90a33d6 2026-06-23 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN MEIJER DISTRIBUTION INC. bc15fea8-0d86-4546-e053-2995a90abee3 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN MEIJER DISTRIBUTION INC. a13ac87b-b395-685e-e053-2a95a90ab5d3 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Whole Foods Market, INC. 32348505-744c-fbfd-e063-6394a90a82d7 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN AMERISOURCE BERGEN 1afcf0c6-bd41-4621-9e44-d97b81221c12 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN AMERISOURCE BERGEN a13cee82-1c4e-0cbe-e053-2a95a90a3ab8 2026-06-23 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions 51de1183-d226-4869-a00a-f6c74e126a39 2026-06-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions 25a94943-9acc-49c8-a4da-7e07bb2c35eb 2026-06-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Topco Associates, LLC 59a88ca7-eb37-46de-9134-a5a6d330bd49 2026-06-23 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