Application 209662

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KLOR-CONPOTASSIUM CHLORIDEFOR SOLUTION;ORAL20MEQNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209662-001KLOR-CONPOTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAA2017-10-23

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A209662-001AA

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KLOR-CONPOTASSIUM CHLORIDEUpsher-Smith Laboratories, LLCe61a4522-b91d-400a-952c-6f035e4610dd2025-07-14Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Gastrointestinal Irritation: Dilute before use, take with meals. ( 5.1 ) 5.1 Gastrointestinal Irritation May cause gastrointestinal irritation. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration (2.1) ].

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0360KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-0360KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-0360KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-0360KLOR-CONpotassium chlorideUpsher-Smith Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50341ORIG2017-11-08