MedPath
FDA Approval

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

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

FDA Approval Summary

Company
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Effective Date
August 11, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Magnesium oxide(3.5 g in 16.1 g)
Picosulfuric acid(10 mg in 16.1 g)
Citric acid(12 g in 16.1 g)

Manufacturing Establishments1

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

Annora Pharma Private Limited

Camber Pharmaceuticals, Inc.

650980746

Products1

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

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Product Details

NDC Product Code
31722-874
Application Number
ANDA212789
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 11, 2022
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBNClass: IACT
Magnesium oxideActive
Code: 3A3U0GI71GClass: ACTIMQuantity: 3.5 g in 16.1 g
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01Class: IACT
Picosulfuric acidActive
Code: LR57574HN8Class: ACTIBQuantity: 10 mg in 16.1 g
Citric acidActive
Code: XF417D3PSLClass: ACTIBQuantity: 12 g in 16.1 g
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy