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Last Updated: November 21, 2024

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, Ani Pharms, Ascent Pharms Inc, Bionpharma, Hibrow Hlthcare, Rising, Strides Pharma, Teva Pharms Usa Inc, Torrent, and Zydus Pharms, and is included in ten NDAs. It is available from thirteen 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 forty drug master file entries for this compound. Sixteen 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
Ingredient:potassium citrate
Patents:0
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 Golden State Medical Supply, Inc. 51407-449 51407-449-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-449-01)
POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 203546 ANDA Golden State Medical Supply, Inc. 51407-450 51407-450-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-450-01)

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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