Application 214071

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	SUSPENSION/DROPS;ORAL	50MG/1.25ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214071-001	IBUPROFEN	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL			2022-06-09

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
2026-09-14 22:38:34	2026-08	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214071-001	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS / ORAL	2022-06-09	`a50c72e98297…`

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 28 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Infants Ibuprofen	IBUPROFEN	Topco Associates LLC	00d33273-e8c7-4d40-8e6f-a980f746fff2	2025-05-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	3732defa-67c2-4b84-8a84-4bbc27b6cb24	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	689dbbe8-4f85-48fe-8efc-fda81b60d37f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	09621787-9a5c-4abf-9ccd-d6f8d581738f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	42b92fd7-468c-4fb8-9ff0-31296735df4c	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	7942cc53-1268-4e5f-8db0-f0b3524bb744	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	c5eaa3a9-5aa8-46b0-8cec-639bfb327475	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
profen ib	IBUPROFEN	Publix Super Markets Inc	bee4b754-c476-4d0e-a1b4-4db8861af84a	2025-05-01	Warnings	Name fallback generic name: IBUPROFEN
Dye Free Childrens Ibuprofen	IBUPROFEN	CVS	2cf2a4de-29d3-8af5-e063-6294a90a9cee	2025-05-01	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen childrens	IBUPROFEN	L. Perrigo Company	6127469c-143f-4dd2-bd37-6630291fcd5a	2025-04-30	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen childrens	IBUPROFEN	CVS Pharmacy	4459298c-e0bf-4a10-b68c-6f83fefde7e9	2025-04-29	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	H E B	bbcfea51-4c57-4a2c-a0ac-2a189c5ff38a	2025-04-28	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
DG Health Ibuprofen	IBUPROFEN	Dolgencorp Inc	0c0cf516-b3e7-474d-885c-897574365be3	2025-04-28	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen childrens	IBUPROFEN	Meijer Distribution Inc	c5e1d74d-99a3-4b3d-86c4-03f5c4c22f77	2025-04-27	Warnings	Name fallback generic name: IBUPROFEN
kirkland signature ibuprofen	IBUPROFEN	Costco Wholesale Company	65d8d650-9afc-44f7-9409-a3aa3014d4ab	2025-04-24	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	A-S Medication Solutions	504c7e5d-e721-4df8-865b-8ea17559831d	2025-04-24	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	334e40f3-6da4-ecbe-e063-6294a90a35bf	2025-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Equaline Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	5e860059-afc8-419e-9451-b1c2265f5ce6	2025-04-18	Warnings	Name fallback generic name: IBUPROFEN
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	a5701486-0a5f-4645-91ef-1fbf525c84dd	2025-04-18	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Meijer Distribution Inc	02681a10-eb8a-457f-8aff-12e6f29079de	2025-04-18	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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59556-149	Ibuprofen	Ibuprofen	Strides Pharma Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71682	ORIG	2022-08-01