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LITHIUM CARBONATE

LITHIUM CARBONATE Extended Release Tablets USP, 300 mg

Approved
Approval ID

722ba14f-fd79-413e-bc1d-21fc10718e90

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

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

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5239
Application NumberANDA076832
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lithium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2011
FDA Product Classification

INGREDIENTS (6)

POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LITHIUM CARBONATEActive
Quantity: 300 mg in 1 1
Code: 2BMD2GNA4V
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT

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LITHIUM CARBONATE - FDA Drug Approval Details