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Details for New Drug Application (NDA): 202219

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NDA 202219 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: 202219

Mylan Pharms Inc
lithium carbonate
Therapeutic Class:Bipolar Agents

Pharmacology for NDA: 202219

Suppliers and Packaging for NDA: 202219

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lithium carbonate
TABLET, EXTENDED RELEASE;ORAL 202219 ANDA Mylan Pharmaceuticals Inc. 0378-1450 0378-1450-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1450-01)
lithium carbonate
TABLET, EXTENDED RELEASE;ORAL 202219 ANDA Mylan Institutional Inc. 51079-142 51079-142-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-142-20) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-142-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength450MG
Approval Date:Aug 8, 2012TE:ABRLD:No

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