Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203546

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POTASSIUM CITRATE (POTASSIUM CITRATE)
5MEQ
Marketing Status: Prescription

Active Ingredient: POTASSIUM CITRATE
Proprietary Name: POTASSIUM CITRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MEQ
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203546
Product Number: 001
Approval Date: Aug 6, 2014
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: POTASSIUM CITRATE
Proprietary Name: POTASSIUM CITRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MEQ
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203546
Product Number: 002
Approval Date: Aug 6, 2014
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: POTASSIUM CITRATE
Proprietary Name: POTASSIUM CITRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MEQ
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203546
Product Number: 003
Approval Date: Aug 6, 2014
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information