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Potassium-cit

These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended- release tablets, for oral use Initial U.S. Approval: 1985

Approved
Approval ID

5ccd4d38-0dcd-4bf7-96fd-a263ff468e1a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2021

Manufacturers
FDA

Eywa Pharma Inc

DUNS: 080465609

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Potassium-cit

PRODUCT DETAILS

NDC Product Code71930-050
Application NumberANDA214426
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 7, 2022
Generic NamePotassium-cit

INGREDIENTS (3)

POTASSIUM CITRATEActive
Quantity: 15 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

potassium-cit

PRODUCT DETAILS

NDC Product Code71930-049
Application NumberANDA214426
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 7, 2022
Generic Namepotassium-cit

INGREDIENTS (3)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 10 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Potassium-cit

PRODUCT DETAILS

NDC Product Code71930-048
Application NumberANDA214426
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 7, 2022
Generic NamePotassium-cit

INGREDIENTS (3)

POTASSIUM CITRATEActive
Quantity: 5 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Potassium-cit - FDA Drug Approval Details