FDA.reportPublic FDA data

Application 207262

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETHACRYNIC ACIDETHACRYNIC ACIDTABLET;ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207262-001ETHACRYNIC ACIDETHACRYNIC ACID25MGTABLET / ORAL2017-02-23

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
2026-08-01 22:54:322026-06A207262-001ETHACRYNIC ACID25MGTABLET / ORAL2017-02-23a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ethacrynic AcidETHACRYNIC ACIDUpsher-Smith Laboratories, LLCc0b17629-7e4a-4c9c-9577-4f79045646282026-07-06Warnings, Adverse reactionsName fallback
brand name: Ethacrynic Acid
generic name: ETHACRYNIC ACID
Ethacrynic AcidETHACRYNIC ACIDSt. Mary's Medical Park Pharmacyf4e95ca1-502b-5305-e053-2995a90a5dc72026-06-26Warnings, Adverse reactionsName fallback
brand name: Ethacrynic Acid
generic name: ETHACRYNIC ACID
Ethacrynic AcidETHACRYNIC ACIDAmneal Pharmaceuticals NY LLCb9bc3907-bfa7-4d9f-90d9-c2097230f7e42026-04-14Warnings, Adverse reactionsName fallback
brand name: Ethacrynic Acid
generic name: ETHACRYNIC ACID
Ethacrynic acidETHACRYNIC ACIDTRUPHARMA LLC3b2b6ee1-1859-4b02-9ef2-5bbe6427f61a2025-12-01Warnings, Adverse reactionsName fallback
brand name: Ethacrynic acid
generic name: ETHACRYNIC ACID
Ethacrynic AcidETHACRYNIC ACIDLupin Pharmaceuticals, Inc.358dd0c5-4d89-403e-9428-a785ec8628692025-10-30Warnings, Adverse reactionsName fallback
brand name: Ethacrynic Acid
generic name: ETHACRYNIC ACID
Ethacrynic AcidETHACRYNIC ACIDEdenbridge Pharmaceuticals LLC.de7c25a6-ed00-4ef3-883d-f8841f5dbd022025-08-11Warnings, Adverse reactionsName fallback
brand name: Ethacrynic Acid
generic name: ETHACRYNIC ACID
Ethacrynic AcidETHACRYNIC ACIDBryant Ranch Prepackfd1b7fb4-fe56-4f2d-860d-bbcea16adfea2025-02-04Warnings, Adverse reactionsName fallback
brand name: Ethacrynic Acid
generic name: ETHACRYNIC ACID
Ethacrynic AcidETHACRYNIC ACIDScieGen Pharmaceuticals Incd400d264-c231-4bdf-8180-eb11ab4e9f292024-12-24Warnings, Adverse reactionsName fallback
brand name: Ethacrynic Acid
generic name: ETHACRYNIC ACID
ethacrynic acidETHACRYNIC ACIDOceanside Pharmaceuticalsf127598f-e6b3-4c35-800f-76e4217595ae2023-08-31Warnings, Adverse reactionsName fallback
brand name: ethacrynic acid
generic name: ETHACRYNIC ACID
EDECRINETHACRYNIC ACIDBausch Health US, LLC1efe378e-fee1-4ae9-8ea5-0fe2265fe2d82020-08-31Warnings, Adverse reactionsName fallback
generic name: ETHACRYNIC ACID

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0415Ethacrynic AcidEthacrynic AcidWest-Ward Pharmaceuticals Corp.ANDACurrent
60429-887Ethacrynic AcidEthacrynic AcidGolden State Medical Supply, Inc.ANDACurrent