FDA.reportPublic FDA data

Application 220683

Type
ANDA
Sponsor
CAPLIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM PHOSPHATESSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESOLUTION;INTRAVENOUS1.34GM/5ML;1.38GM/5ML (268MG/ML; 276MG/ML)NoNo
002SODIUM PHOSPHATESSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESOLUTION;INTRAVENOUS4.02GM/15ML;4.14GM/15ML (268MG/ML; 276MG/ML)NoNo
003SODIUM PHOSPHATESSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESOLUTION;INTRAVENOUS13.4GM/50ML;13.8GM/50ML (268MG/ML; 276MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220683-001SODIUM PHOSPHATESSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE1.34GM/5ML;1.38GM/5ML (268MG/ML; 276MG/ML)SOLUTION / INTRAVENOUSAP2026-02-23
A220683-002SODIUM PHOSPHATESSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE4.02GM/15ML;4.14GM/15ML (268MG/ML; 276MG/ML)SOLUTION / INTRAVENOUSAP2026-02-23
A220683-003SODIUM PHOSPHATESSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE13.4GM/50ML;13.8GM/50ML (268MG/ML; 276MG/ML)SOLUTION / INTRAVENOUSAP2026-02-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A220683-001AP
A220683-002AP
A220683-003AP

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220683-001SODIUM PHOSPHATES1.34GM/5ML;1.38GM/5ML (268MG/ML; 276MG/ML)SOLUTION / INTRAVENOUSAP2026-02-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220683-002SODIUM PHOSPHATES4.02GM/15ML;4.14GM/15ML (268MG/ML; 276MG/ML)SOLUTION / INTRAVENOUSAP2026-02-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220683-003SODIUM PHOSPHATES13.4GM/50ML;13.8GM/50ML (268MG/ML; 276MG/ML)SOLUTION / INTRAVENOUSAP2026-02-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220683-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220683-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220683-003AP1a50c72e98297…

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM PHOSPHATESSODIUM PHOSPHATESGLENMARK PHARMACEUTICALS INC., USAc968f70b-a670-4aef-a7e0-89468ad62d9c2026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220683
application number: ANDA220683
SODIUM PHOSPHATESSODIUM PHOSPHATESCaplin Steriles Limited46de992b-5fc8-4dad-8d95-77938decb67e2026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220683
application number: ANDA220683