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 47 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen Childrens	IBUPROFEN	H E B	0a9a54ce-572f-4a96-922f-cc136d2d4aad	2018-06-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Breeden Brothers, LLC	e4314153-479d-4c0f-ba49-4d4efded304b	2018-04-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	acc4cbc8-085d-42f3-ad93-113e0b55631c	2017-11-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS PHARMACY, INC.	cdd5a402-df90-4a16-a38c-78eab7189998	2017-11-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Fast Pain Relief	IBUPROFEN	HealthLife of USA LLC	a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65	2017-06-05	Warnings	Name fallback generic name: IBUPROFEN
Dye Free Ibuprofen	IBUPROFEN	Breeden Brothers, LLC	ba106f6f-2c6b-4c98-a10e-d27622b08b25	2017-02-15	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