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Details for New Drug Application (NDA): 018421

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NDA 018421 describes LITHIUM CITRATE, which is a drug marketed by Roxane and Wockhardt and is included in two NDAs. It is available from four suppliers. Additional details are available on the LITHIUM CITRATE profile page.

The generic ingredient in LITHIUM CITRATE is lithium citrate. There are fifteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lithium citrate profile page.

Summary for NDA: 018421

lithium citrate
Therapeutic Class:Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018421

Suppliers and Packaging for NDA: 018421

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lithium citrate
SYRUP;ORAL 018421 NDA West-Ward Pharmaceuticals Corp 0054-3527 0054-3527-63 500 mL in 1 BOTTLE (0054-3527-63)
lithium citrate
SYRUP;ORAL 018421 NDA Cardinal Health 55154-4952 55154-4952-5 5 CUP, UNIT-DOSE in 1 BAG (55154-4952-5) > 5 mL in 1 CUP, UNIT-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 300MG CARBONATE/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

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