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 35 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	A-S Medication Solutions	0ce79e85-0b8b-436e-b895-ea5c02eaf4ba	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	8d41cc03-dec6-4949-b7c1-7deb2897e2c4	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	23fb1113-9f1c-88e0-e063-6394a90a4450	2024-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	P & L Development, LLC	1f9c94a6-938a-420f-b90c-36b3791e97ad	2024-10-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	43ac478c-43db-4136-8fee-4a43b09681e5	2024-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	H E B	2f193146-74b2-4941-893d-3d2f5c8ee659	2024-10-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	307b0257-d636-416b-828a-f901782e9b10	2024-09-13	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	ca81671d-1ea8-4c67-802f-adb3a2f087cc	2024-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	214e3b3e-87b9-9ff5-e063-6394a90ae96a	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	e54209c2-f726-440b-ac60-5a72710d2a9b	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	82aad715-f652-471b-840c-5151c66e5ade	2024-08-28	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen Minis	IBUPROFEN	Harris Teeter	180557e4-335e-f520-e063-6394a90a2fa4	2024-08-20	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d0198bdc-fe2b-4b09-8f78-9e5a7f6ae784	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Wildman Business Group	9e71f1c1-5272-4209-8974-6c525b141155	2024-08-19	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	593d9870-0213-75e6-e053-2991aa0a0eff	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
IBU	IBUPROFEN	NuCare Pharmaceuticals Inc.	575c275c-3e1a-0572-e053-2991aa0adabd	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Granules India Limited	fd01353d-1d1d-42b5-9a03-575052189bf5	2024-08-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Florida Pharmaceutical Products, LLC	c1733fdb-5eed-2094-e053-2995a90a6c8e	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	60f1c099-5fb5-47e8-b228-11de1ef40f4b	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	ffc953f7-ed92-4528-bb2f-72c634c119fa	2024-08-08	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