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 34 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
kirkland signature ibuprofen ib	IBUPROFEN	Costco Wholesale Company	2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c	2024-10-14	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b87cf806-1635-44d5-a9de-383081cb37d8	2024-10-14	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	df0e55d0-617c-4084-984f-ece2f640e715	2024-10-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b0917020-f0ec-4d07-8fbf-c1eb909f466b	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b365be3a-91ad-46bf-a949-103c81f2359a	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Westminster Pharmaceuticals, LLC	eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	0ce79e85-0b8b-436e-b895-ea5c02eaf4ba	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	8d41cc03-dec6-4949-b7c1-7deb2897e2c4	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	23fb1113-9f1c-88e0-e063-6394a90a4450	2024-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	P & L Development, LLC	1f9c94a6-938a-420f-b90c-36b3791e97ad	2024-10-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	43ac478c-43db-4136-8fee-4a43b09681e5	2024-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	H E B	2f193146-74b2-4941-893d-3d2f5c8ee659	2024-10-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	307b0257-d636-416b-828a-f901782e9b10	2024-09-13	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	ca81671d-1ea8-4c67-802f-adb3a2f087cc	2024-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	214e3b3e-87b9-9ff5-e063-6394a90ae96a	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	e54209c2-f726-440b-ac60-5a72710d2a9b	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	82aad715-f652-471b-840c-5151c66e5ade	2024-08-28	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen Minis	IBUPROFEN	Harris Teeter	180557e4-335e-f520-e063-6394a90a2fa4	2024-08-20	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d0198bdc-fe2b-4b09-8f78-9e5a7f6ae784	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Wildman Business Group	9e71f1c1-5272-4209-8974-6c525b141155	2024-08-19	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.

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