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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203546

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NDA 203546 describes POTASSIUM CITRATE, which is a drug marketed by Ut Sw Medctr, Impax Labs Inc, Strides Pharma, and Zydus Pharms Usa Inc, and is included in four NDAs. It is available from five suppliers. Additional details are available on the POTASSIUM CITRATE profile page.

The generic ingredient in POTASSIUM CITRATE is potassium citrate. There are two hundred and thirty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the potassium citrate profile page.
Summary for 203546
Tradename:POTASSIUM CITRATE
Applicant:Zydus Pharms Usa Inc
Ingredient:potassium citrate
Patents:0
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details
Pharmacology for NDA: 203546
Medical Subject Heading (MeSH) Categories for 203546
Suppliers and Packaging for NDA: 203546
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 203546 ANDA Cadila Healthcare Limited 65841-536 65841-536-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-536-01)
POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 203546 ANDA Cadila Healthcare Limited 65841-536 65841-536-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-536-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MEQ
Approval Date:Aug 6, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MEQ
Approval Date:Aug 6, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MEQ
Approval Date:Aug 6, 2014TE:ABRLD:No

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