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 36 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	19b06eaf-0d4c-2b4d-e063-6294a90a2eb9	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	P & L Development, LLC	6d1c9a64-c83c-4b3d-9245-704b94cb367c	2024-07-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	faebc392-0fd9-4c71-8471-beba10dda022	2024-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Actavis Pharma, Inc.	3d156d13-25d8-4cfc-8285-5f7ebf48cf45	2024-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	678e2d16-33f3-67a7-e053-2991aa0a1132	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	75d963b9-3675-44ff-bc6b-83461bed1b67	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	57cdd1df-a303-4265-a2d6-1d0b87105a28	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	8df77ead-27eb-4f6f-95a9-f68d3e9cfa71	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	54b25106-5580-119d-e054-00144ff88e88	2024-07-17		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Bryant Ranch Prepack	22cb2ccc-ba4d-4069-8334-f886f0e3e802	2024-07-12	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Foster and Thrive Infants Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	fe3092af-9a7b-4189-af89-31be8d6fed53	2024-07-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	92efad86-31ae-78e5-e053-2995a90a0fda	2024-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	3e3848f2-4922-39ea-e054-00144ff88e88	2024-06-25	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	999aa615-72b2-9296-e053-2a95a90ac70b	2024-06-20		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
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

Reported adverse events (FAERS/openFDA)#

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