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	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 3 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals LLC	17577b3b-e755-45d1-8b53-775d058578b2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	b5a47efe-222f-4cbd-b649-caafd16a0829	2026-07-29	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Harris Teeter	637210f0-6494-4656-8b2b-14d7476cb127	2026-07-29	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Harris Teeter	9d5c994a-8363-4ddb-956c-e12b79a32a58	2026-07-29	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Harris Teeter	87ffbf01-54de-45a8-b2a3-367d21927882	2026-07-29	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Harris Teeter	14515409-736f-4119-b6a0-cb19ee2e948e	2026-07-29	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Harris Teeter	1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc633	2026-07-29	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ADVIL MIGRAINE	IBUPROFEN	Haleon US Holdings LLC	e4a6219d-4ad4-0119-4cf8-7fc39b4b5979	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Advil	IBUPROFEN	Haleon US Holdings LLC	1f01c10a-9434-91a4-2ee4-352315a6b610	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	H E B	21567c0f-abba-4a40-a0b9-5ce49b3d9648	2026-07-28	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	656658cc-8cf0-42b6-af4f-4e3ab7648625	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	a7756b22-73cf-4262-aa8e-0577ddecd03b	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	1ca722bb-940e-4b3e-9561-d87e2feb1ff8	2026-07-24	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	fc6c29b4-f1b3-4cfe-8c96-564d083be39c	2026-07-24	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Rite Aid Corporation	26bccfc1-bc8d-4241-a078-c760048951c9	2026-07-24	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	HF Acquisition Co LLC, DBA HealthFirst	574b6f15-70bc-fca7-e063-6294a90a0455	2026-07-23	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Safeway, Inc.	a530d43d-e9c4-4edb-af66-c92860e46f45	2026-07-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TWIN MED LLC	f03958f8-aeae-edf0-e053-2a95a90a3e9e	2026-07-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Good Sense ibuprofen	IBUPROFEN	L. Perrigo Company	aebae4b3-18c8-4ecf-b578-1fe7cc50076b	2026-07-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	d3a7ebef-f7ab-4b34-b62e-278a8deabf78	2026-07-21	Boxed warning, Warnings, Adverse reactions	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 · 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