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 44 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
betr pain relief	IBUPROFEN	Live Betr LLC	1b709dce-5c71-45e6-b516-d510a0a8c25d	2022-08-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e5bf5e09-7d42-6314-e053-2a95a90a2325	2022-08-08	Warnings	Name fallback brand name: Ibuprofen
Ibuprofen	IBUPROFEN	DOLGENCORP, INC.	df321783-73cb-55bf-e053-2a95a90a4ce2	2022-07-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	b7565aac-a928-4116-b9af-cf636da4537c	2022-07-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CARDINAL HEALTH	dfbbde4f-633d-6d57-e053-2a95a90ad82f	2022-05-24	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	7779c369-50bf-4cde-9015-ff3fb35e128e	2022-05-16	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	d2c7f045-e70c-4e2b-b2e0-d81a271d0a04	2022-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Jones Healthcare Group - Packaging Services, Inc	6419cc78-27d4-7713-e053-2a91aa0a5a10	2022-04-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	2dc3108f-d917-40c6-865d-c900cf055d1c	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Proficient Rx LP	798d33b0-5d7a-4445-8a51-2a3d336f744a	2022-04-01	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	444b2ea0-ec42-4bcf-b8d2-38b4b297ada0	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	1100648c-6b9f-49c9-94d0-c40f24fe5c27	2022-03-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	9bbbedb3-e0b2-4645-8105-98800096cfed	2022-03-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	3b0e77a1-b49d-4c67-81dd-66450dabcf3b	2022-03-04	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	0ade8ee2-7c74-4b05-925e-d92742fc2b90	2022-03-03	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	cf6fbf3b-a0f3-4e08-a981-d183fa285758	2022-03-03	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	91723661-d0bb-4498-ac59-59bbdc334230	2022-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Pain Relief - Ibuprofen 200 mg	IBUPROFEN	Health Pharma USA LLC	d60a6a11-8c06-cede-e053-2a95a90af7f9	2022-01-20	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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