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FDA Approval

TRICITRATES

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Effective Date

August 21, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Potassium citrate(550 mg in 5 mL)

VS-01(334 mg in 5 mL)

Sodium citrate(500 mg in 5 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

ATLANTIC BIOLOGICALS CORP.

Labeler

ATLANTIC BIOLOGICALS CORP.

DUNS Number

047437707

Products1

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

TRICITRATES

Product Details

NDC Product Code

17856-0677

Route of Administration

ORAL

Effective Date

September 26, 2018

Ingredients

Potassium citrateActive

Code: EE90ONI6FFClass: ACTIBQuantity: 550 mg in 5 mL

VS-01Active

Code: 2968PHW8QPClass: ACTIMQuantity: 334 mg in 5 mL

Sodium citrateActive

Code: 1Q73Q2JULRClass: ACTIBQuantity: 500 mg in 5 mL

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

CONTRAINDICATIONS SECTION

CONTRAINDICATIONS

Severe renal impairment with oliguria or azotemia, untreated Addison's disease, or severe myocardial damage. In certain situations, when patients are on a sodium-restricted diet, the use of potassium citrate may be preferable; or, when patients are on a potassium-restricted diet, the use of sodium citrate may be preferable.

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