Application 071267

Type: ANDA
Sponsor: CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 45 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Concentrated ibuprofen infants	IBUPROFEN	Wal-Mart Stores, Inc.	00b7fc71-8cf0-4c12-a479-146408f7f91b	2022-01-11	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7aa790a-6d6c-7929-e053-2995a90a1cf8	2022-01-04	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	RITE AID	a7abf95e-d444-42da-e053-2995a90a88d3	2022-01-03	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	RITE AID	a7ac8b55-2758-400e-e053-2995a90a0eed	2022-01-03	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	3c8df1e5-61bc-4e70-b6b9-8973986ad589	2021-12-21	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	859d7190-586f-4766-a7e7-9e800a72d58b	2021-12-21	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	0dec2df9-ba8b-4bc7-b617-773aa08f9273	2021-12-20	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen 200 mg	IBUPROFEN	Allegiant Health	8ba06ba0-bfe9-4626-af65-dae4d6a3a2ad	2021-12-06	Warnings	Name fallback generic name: IBUPROFEN
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	b2a14686-6083-46a1-885c-9f7c30e9c647	2021-11-30	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen 200mg	IBUPROFEN	Allegiant Health	f3f12b86-89dc-427e-a26f-728be6f73e7b	2021-11-16	Warnings	Name fallback generic name: IBUPROFEN
infants ibuprofen	IBUPROFEN	H E B	2c67fecb-2e69-44d6-8ab8-3251abae72a6	2021-11-16	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	c13455a3-307a-4fe1-e053-2a95a90adf8e	2021-11-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7abac4c-7695-cfe8-e053-2a95a90ac1cd	2021-10-30	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Childrens Ibuprofen bubblegum	IBUPROFEN	Guardian Drug Company	9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	2021-10-13	Warnings	Name fallback generic name: IBUPROFEN
basic care infants ibuprofen	IBUPROFEN	Amazon.com Services LLC	1b5b96cc-40d4-4fb8-b429-cc1a5076fa77	2021-10-08	Warnings	Name fallback generic name: IBUPROFEN
rexall ibuprofen	IBUPROFEN	Dolgencorp, LLC	869185d5-9f34-4d38-9551-dd0b4fc8557d	2021-09-09	Warnings	Name fallback generic name: IBUPROFEN
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	1204267a-5505-4257-837b-8902b7571347	2021-09-07	Warnings	Name fallback generic name: IBUPROFEN
Migraine Relief	IBUPROFEN	Bionpharma Inc.	662ae0e0-bd44-4db4-8083-fc2e11d49abe	2021-08-24	Warnings	Name fallback generic name: IBUPROFEN
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	b17b0aac-55d2-4917-a722-b8587ad643bc	2021-08-13	Warnings	Name fallback generic name: IBUPROFEN
dg health childrens ibuprofen	IBUPROFEN	Dolgencorp, LLC	ad8475b3-ace1-4a05-b927-3286a8139cb4	2021-05-26	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.