FDA.reportPublic FDA data

Application 214071

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENSUSPENSION/DROPS;ORAL50MG/1.25MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214071-001IBUPROFENIBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-0984e616aacf4f…
2026-08-18 06:07:402026-07A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214071-001IBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORAL2022-06-09a50c72e98297…

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 20 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENRite Aid Corporation1dba3cb7-2e3d-4378-93cf-92db8f24f41f2025-10-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
RIGHT REMEDIES Ibuprofen 200 MGIBUPROFENStrive Pharmaceuticals Inc.5c155210-d16f-487e-983d-c7b0f97365c62025-10-08WarningsName fallback
generic name: IBUPROFEN
Childrens MotrinIBUPROFENKenvue Brands LLC63ec7636-bf2a-4d52-ab88-fb93d41661ec2025-10-08WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC6521bc47-4d9c-4a5b-b109-3841f3be4b6c2025-10-07WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens MotrinIBUPROFENKenvue Brands LLC15b0b56d-6188-4937-b541-902022e35b242025-10-07WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INCbfda6547-19b2-4230-87a1-a68fbec740b42025-10-06WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Motrin IBIBUPROFENKenvue Brands LLCd21129f8-4d96-4e36-bc39-a534306dd77e2025-10-03WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPHOENIX RX LLC40202c76-4275-88fd-e063-6394a90a07b22025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
careone ibuprofenIBUPROFENAmerican Sales Company2720b8aa-4361-4cd4-be26-aa6dd1692d122025-10-01WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.a1a5a9c7-c727-4e41-a8f0-2982f796a3ca2025-09-29WarningsName fallback
generic name: IBUPROFEN
leader ibuprofenIBUPROFENCardinal Health 110, LLC. dba Leader96da60f7-06a9-438a-ae59-8609fdd1587d2025-09-25WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENKroger Companybc173f1b-2e44-2c2e-e053-2a95a90a89c42025-09-24WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IBUPROFENIBUPROFENKroger Companybbedfc37-913d-8046-e053-2995a90af68a2025-09-24WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
pain reliefIBUPROFENMeijer, Inc.ae39917e-1998-4298-8686-919c0d3c2b072025-09-19WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack7acdd557-0b6c-48f5-9437-7bc567af1f852025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension Dye FreeIBUPROFENFSA Store Inc. (Caring Mill)099e374b-49c2-4d56-a047-d4f0c4af34ba2025-09-18WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.06710aef-2631-4925-8e9e-33bae84b59122025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack86fc38bc-7f54-4aab-9c4d-d0898a4381f92025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepackd50f829d-071f-4299-9b74-0f28caac71182025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENMeijer Distribution Ince28e64dc-5f4e-4260-953a-3de38a5eaa762025-09-15WarningsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59556-149IbuprofenIbuprofenStrides Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71682ORIG2022-08-01