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 21 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENCVS Pharmacy. Inc.d4336a7c-fb9f-1fbe-e053-2995a90af3652025-09-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCVS Pharmacy.Inc.cd0c3404-9e9d-bfad-e053-2995a90a87192025-09-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENA-S Medication Solutions7d4ba8be-df59-4a21-8850-8a59bf72b6042025-09-11WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack894a5d14-e405-43ac-a5a2-0b4de5b284742025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENHEBacf86f62-1d55-4281-95b7-8b2b51eb7c892025-09-10WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENHEBc04ad0b4-5d8a-4861-9eaa-b2aaa7b196642025-09-10WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Green Guard Ibupro reliefIBUPROFENUnifirst First Aid Corporation2923c4a3-f994-67a7-e054-00144ff8d46c2025-09-09WarningsName fallback
generic name: IBUPROFEN
Medique IprinIBUPROFENUnifirst First Aid Corporation2910b50b-c8de-382b-e054-00144ff88e882025-09-09WarningsName fallback
generic name: IBUPROFEN
Green Guard Ibuprofen ReliefIBUPROFENUnifirst First Aid0798e401-8247-2fce-e054-00144ff8d46c2025-09-09WarningsName fallback
generic name: IBUPROFEN
Medique at Home IprinIBUPROFENUnifirst First Aid Corporationb5547f33-2a81-867d-e053-2995a90aa2d02025-09-09WarningsName fallback
generic name: IBUPROFEN
Medique IprinIBUPROFENUnifirst First Aid Corporation0607edb0-1b3a-2ccd-e054-00144ff8d46c2025-09-09WarningsName fallback
generic name: IBUPROFEN
Direct Safety IbuprofenIBUPROFENConney Safety Products, LLC28d45743-d298-29db-e054-00144ff8d46c2025-09-09WarningsName fallback
generic name: IBUPROFEN
Unishield IbuprofenIBUPROFENUnishieldb9e2e2ba-e2ad-eace-e053-2995a90aed352025-09-09WarningsName fallback
generic name: IBUPROFEN
Direct Safety IbuprofenIBUPROFENConney Safety Products, LLC07afce34-aaea-50a1-e054-00144ff88e882025-09-09WarningsName fallback
generic name: IBUPROFEN
Uline IbuprofenIBUPROFENUlined7342a15-9d49-74ed-e053-2a95a90a22cc2025-09-09WarningsName fallback
generic name: IBUPROFEN
McKesson Ibuprofen 200 mgIBUPROFENMcKesson Medical-Surgicalca75b9fe-5bc8-ab90-e053-2995a90a52fb2025-09-09WarningsName fallback
generic name: IBUPROFEN
Henry Schein IbuprofenIBUPROFENHenry Schein Inc.267c7c8a-2f3f-1f4d-e054-00144ff8d46c2025-09-08WarningsName fallback
generic name: IBUPROFEN
Ibuprofen ThompsonIBUPROFENThompson Safetyccfbc048-f666-3188-e053-2995a90ae08f2025-09-08WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENWalgreen Company37c9b887-190a-4daf-8199-f406913132f02025-09-03WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENSam's West Inc6293a134-860d-4d12-9e4b-28490f8241082025-09-03WarningsName 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