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Last Updated: April 17, 2021

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Details for New Drug Application (NDA): 206813

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NDA 206813 describes POTASSIUM CITRATE, which is a drug marketed by Ut Sw Medctr, Ani Pharms Inc, Bionpharma Inc, Rising, Strides Pharma, Teva Pharms Usa Inc, and Zydus Pharms, and is included in seven NDAs. It is available from nine 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. Twelve suppliers are listed for this compound. Additional details are available on the potassium citrate profile page.
Summary for 206813
Tradename:POTASSIUM CITRATE
Applicant:Strides Pharma
Ingredient:potassium citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206813
Medical Subject Heading (MeSH) Categories for 206813
Suppliers and Packaging for NDA: 206813
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 206813 ANDA Strides Pharma Inc. 42543-406 42543-406-01 100 TABLET in 1 BOTTLE (42543-406-01)
POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 206813 ANDA Strides Pharma Inc. 42543-407 42543-407-01 100 TABLET in 1 BOTTLE (42543-407-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MEQ
Approval Date:Sep 11, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MEQ
Approval Date:Sep 11, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MEQ
Approval Date:Sep 11, 2017TE:ABRLD:No

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