Application 213924

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEMAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATESOLUTION;ORAL1.6GM/BOT;3.13GM/BOT;17.5GM/BOTNoNo

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
A213924-001SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEMAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE1.6GM/BOT;3.13GM/BOT;17.5GM/BOTSOLUTION / ORALAA2023-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A213924-001AA

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 22:54:322026-06A213924-001SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE1.6GM/BOT;3.13GM/BOT;17.5GM/BOTSOLUTION / ORALAA2023-12-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213924-001AA1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Sulfate, Potassium Sulfate and Magnesium SulfateSODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEAscend Laboratories, LLC2106d1aa-086e-4248-9a3d-ec138d492cf32024-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213924
application number: ANDA213924