Home Applications 206990 Application 206990
Type ANDA
Sponsor SHANDONG XINHUA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 200MG No No
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-12-13 00:20 UTC 2019-12 A206990-001 IBUPROFEN 200MG TABLET / ORAL 2018-08-21 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A206990-001 IBUPROFEN 200MG TABLET / ORAL 2018-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206990-001 IBUPROFEN 200MG TABLET / ORAL 2018-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206990-001 IBUPROFEN 200MG TABLET / ORAL 2018-08-21 ea99ee380514…
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 42 of 47 · 926 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 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 Ibuprofen IBUPROFEN Aurohealth LLC e1b49257-d226-457f-8f2d-9a757a65bbcb 2022-09-06 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Childrens Ibuprofen Oral Suspension IBUPROFEN Pharmaceutical Associates, Inc. 7a6832f2-2d80-483c-bde3-e6cacb7c318a 2022-08-31 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 11788-002 Ibuprofen Ibuprofen AiPing Pharmaceutical, Inc. ANDA Current 11788-002 Ibuprofen Ibuprofen AiPing Pharmaceutical, Inc. ANDA Current 11788-004 Ibuprofen Ibuprofen AiPing Pharmaceutical, Inc. ANDA Current 11788-004 Ibuprofen Ibuprofen AiPing Pharmaceutical, Inc. ANDA Current 11788-006 Ibuprofen Ibuprofen AiPing Pharmaceutical, Inc. ANDA Current 11788-006 Ibuprofen Ibuprofen AiPing Pharmaceutical, Inc. ANDA Current