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 33 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	H E B	a340ed68-debb-4c1e-97eb-82f6e9e3854f	2024-12-02	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
365 whole foods market ibuprofen	IBUPROFEN	Whole Foods Market, INC.	e914472b-c785-4c73-b37c-4d459166cf41	2024-11-26	Warnings	Name fallback generic name: IBUPROFEN
INFANTS ADVIL	IBUPROFEN	Haleon US Holdings LLC	db5ed801-7a7e-3c83-0172-77f914daaa5a	2024-11-26	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	1ef5693b-d00a-28fb-e063-6294a90a7ede	2024-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES, INC	ec3e8443-d742-4c25-8516-f0df4ebfccdc	2024-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
dg health ibuprofen	IBUPROFEN	Dolgencorp, LLC	fd27d4e1-8edf-4bc3-a593-6be5c3345ed0	2024-11-13	Warnings	Name fallback generic name: IBUPROFEN
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	4f664479-f68c-464a-956d-25bb9f39c4cc	2024-11-08	Warnings	Name fallback generic name: IBUPROFEN
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	152189e5-391c-42d3-a03b-c8364e2de6bf	2024-11-08	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	A-S Medication Solutions	9ac095d2-ba19-4da1-acc9-85f7b4ae304d	2024-11-04	Warnings	Name fallback generic name: IBUPROFEN
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	9e1cdef7-921f-4163-869c-6c062e31c5bb	2024-11-01	Warnings	Name fallback generic name: IBUPROFEN
Childrens MOTRIN	IBUPROFEN	Kenvue Brands LLC	f2609308-17bf-4bcb-84b2-d17f3fd35958	2024-11-01	Warnings	Name fallback generic name: IBUPROFEN
GOOD REMEDIES ibuprofen 200 mg	IBUPROFEN	Strive Pharmaceuticals Inc.	24fb3741-65e0-898d-e063-6394a90af569	2024-10-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	7650f84b-92f2-4065-8ef2-f5de5bd7002b	2024-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	1361b6d6-0443-460a-8446-41f63a1e28df	2024-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Rugby Laboratories, Inc.	05c4e6c7-bf95-4e05-b7da-7a8778de342b	2024-10-28	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb619068-be71-7569-e053-2a95a90a4a6e	2024-10-26	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Pain Reliever/Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals LLC	877440fc-3afb-4123-a2e6-5cb48c74413c	2024-10-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Pain Reliever/Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals LLC	5f27dd3f-c735-417b-95e6-26dc5aae5a7a	2024-10-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	2d0c2d35-c212-4daa-b2c4-b407ca0b16ad	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	2b470e48-c23c-4f5c-916a-d38d8518896b	2024-10-21	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.

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