Application 072300

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	800MG	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 36 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	9973bfa2-693a-1165-e053-2995a90a4b1d	2024-06-20		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	99d7cf65-3ec2-24eb-e053-2a95a90acc5e	2024-06-20		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	a2160213-2a32-2044-e053-2995a90a21af	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN 200MG	Lil' Drug Store Products, Inc.	8fc65767-1783-4f7f-8680-9e43ba4d5481	2024-06-19	Warnings	Name fallback brand name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	8c3dccbb-1084-cd09-e053-2a95a90ac12a	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	8cb93e5f-4ebc-24b7-e053-2a95a90a5a23	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	88795f0e-41b7-504e-e053-2995a90a3b9e	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen, Circle K, 50ct	IBUPROFEN	Lil' Drug Store Products, Inc.	1ab6fbae-ead5-283b-e063-6394a90a4ed4	2024-06-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Trifecta Pharmaceuticals USA LLC	114b5e23-6cd7-41d8-e063-6294a90aa0f0	2024-06-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	6d86ce94-a06a-2769-e053-2991aa0afb95	2024-06-10		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	6365b2d6-2337-70c0-e053-2a91aa0aa960	2024-06-06		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1a02fa34-b5ae-7183-e063-6294a90a3ae4	2024-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	SKYA HEALTH, LLC	1c28af16-7246-4e4c-a1be-939655c37242	2024-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	SAM'S WEST INC	16595d75-6e74-0839-e063-6394a90abc13	2024-05-28	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen, Lil Drug Store	IBUPROFEN	Lil' Drug Store products, Inc.	18e80dab-6837-fd2d-e063-6294a90a73c8	2024-05-20	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN 100	IBUPROFEN	JHK Inc dba American Safety & First Aid	218f6df9-dd04-45b6-8a45-3276691abee2	2024-04-25	Warnings	Name fallback generic name: IBUPROFEN
JUNIOR STRENGTH ADVIL	IBUPROFEN	Haleon US Holdings LLC	5ed0d404-c54d-b05f-578a-d2730e8a78ee	2024-04-22	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Kroger Company	bc178013-ab2e-04f5-e053-2995a90a1ed4	2024-04-13	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	KROGER COMPANY	0fbe42d0-b5f2-0780-e063-6394a90a4ecb	2024-04-13	Warnings	Name fallback brand name: Ibuprofen
Ibuprofen	IBUPROFEN	KROGER COMPANY	0fbe42d0-b5f0-0780-e063-6394a90a4ecb	2024-04-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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