FDA.reportPublic FDA data

Application 210200

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDEPOTASSIUM CHLORIDEFOR SOLUTION;ORAL20MEQNoNo

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
A210200-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2018-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210200-001AA

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 22:54:322026-06A210200-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2018-11-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210200-001AA1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEVirtus Pharmaceuticals, LLCb43b84ea-babd-477b-b69b-811657bc15032026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210200
application number: ANDA210200
ndc (product): 69543-451
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEEpic Pharma, LLC1373321f-533a-4ab4-8bcd-8bde15371a092024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210200
application number: ANDA210200
ndc (product): 42806-094
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack7a220e87-ff72-417b-bc45-90a37b7f2aa62024-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210200
application number: ANDA210200

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-094Potassium ChloridePotassium ChlorideEpic Pharma, LLCANDACurrent
42806-094Potassium ChloridePotassium ChlorideEpic Pharma, LLCANDACurrent
42806-094POTASSIUM CHLORIDEPOTASSIUM CHLORIDEEpic Pharma, LLCANDACurrent
42806-094Potassium ChloridePotassium ChlorideEpic Pharma, LLCANDACurrent
69543-451Potassium ChloridePotassium ChlorideVirtus Pharmaceuticals, LLCANDACurrent
69543-451Potassium ChloridePotassium ChlorideVirtus Pharmaceuticals, LLCANDACurrent
69543-451Potassium ChloridePotassium ChlorideVirtus Pharmaceuticals, LLCANDACurrent