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Details for New Drug Application (NDA): 090702

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NDA 090702 describes LITHIUM CARBONATE, which is a drug marketed by Hetero Labs Ltd Iii, Watson Labs, Roxane, Hikma Intl Pharms, Glenmark Generics, Mylan Pharms Inc, Able, Sun Pharm Inds Inc, Heritage Pharma, Pfizer, Usl Pharma, Delcor Asset Corp, Glenmark Pharms Inc, Alembic Pharms Ltd, Alembic Ltd, Barr, Unique Pharm Labs, and Apotex Inc, and is included in twenty-eight NDAs. It is available from thirty-four suppliers. Additional details are available on the LITHIUM CARBONATE profile page.

The generic ingredient in LITHIUM CARBONATE is lithium carbonate. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.

Summary for NDA: 090702

Hetero Labs Ltd Iii
lithium carbonate
Therapeutic Class:Bipolar Agents

Pharmacology for NDA: 090702

Suppliers and Packaging for NDA: 090702

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lithium carbonate
CAPSULE;ORAL 090702 ANDA Camber Pharmaceuticals Inc. 31722-544 31722-544-01 100 CAPSULE in 1 BOTTLE (31722-544-01)
lithium carbonate
CAPSULE;ORAL 090702 ANDA Camber Pharmaceuticals Inc. 31722-544 31722-544-05 500 CAPSULE in 1 BOTTLE (31722-544-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Sep 25, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Sep 25, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength600MG
Approval Date:Sep 25, 2009TE:ABRLD:No

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