Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209922

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POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
10MEQ
Marketing Status: Prescription

Active Ingredient: POTASSIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MEQ
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A209922
Product Number: 001
Approval Date: Apr 30, 2019
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
15MEQ
Marketing Status: Prescription

Active Ingredient: POTASSIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MEQ
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A209922
Product Number: 002
Approval Date: Apr 30, 2019
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
20MEQ
Marketing Status: Prescription

Active Ingredient: POTASSIUM CHLORIDE
Proprietary Name: POTASSIUM CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MEQ
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A209922
Product Number: 003
Approval Date: Apr 30, 2019
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information