Application 211992

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDESOLUTION;ORAL20MEQ/15MLNoNo
002POTASSIUM CHLORIDEPOTASSIUM CHLORIDESOLUTION;ORAL40MEQ/15MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211992-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-04-09
A211992-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-04-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A211992-001AA
A211992-002AA

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
2026-08-18 06:07:402026-07A211992-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07A211992-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-04-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211992-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211992-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211992-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211992-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211992-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211992-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-04-096a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211992-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAA2025-04-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211992-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAA2025-04-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211992-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A211992-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211992-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211992-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211992-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211992-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211992-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211992-002AA16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211992-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211992-002AA1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium chloridePOTASSIUM CHLORIDECamber Pharmaceuticals, Inc.fb2f6e74-4c1f-40c5-88a1-b88c069d4c752025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211992
application number: ANDA211992