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Carglumic acid

These highlights do not include all the information needed to use CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION. CARGLUMIC ACID tablets for oral suspension Initial U.S. Approval: 2010

Approved
Approval ID

59e73eb8-edf8-4fad-93c2-deb6b23497f8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 10, 2023

Manufacturers
FDA

Navinta LLC

DUNS: 130443810

Products 1

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

Carglumic acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68475-006
Application NumberANDA213395
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carglumic acid
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2023
FDA Product Classification

INGREDIENTS (7)

MICROCRYSTALLINE CELLULOSEInactive
Quantity: 167.7 mg in 1 1
Code: OP1R32D61U
Classification: IACT
CARGLUMIC ACIDActive
Quantity: 200 mg in 1 1
Code: 5L0HB4V1EW
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Quantity: 25 mg in 1 1
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSE 105Inactive
Quantity: 100.3 mg in 1 1
Code: KO5GYV0DCB
Classification: IACT
SODIUM LAURYL SULFATEInactive
Quantity: 0.5 mg in 1 1
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Quantity: 5 mg in 1 1
Code: 7CV7WJK4UI
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 1.5 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT

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Carglumic acid - FDA Drug Approval Details