Details for New Drug Application (NDA): 079139
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NDA 079139 describes LITHIUM CARBONATE, which is a drug marketed by Able, Alembic Ltd, Apotex Inc, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Hikma, Norvium Bioscience, Usl Pharma, Watson Labs, Alembic, Glenmark Pharms Inc, Heritage Pharma, Hikma Intl Pharms, Mylan Pharms Inc, Unique, Pfizer, and Sun Pharm Inds Inc, and is included in twenty-nine NDAs. It is available from twenty-three 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. Twenty-four suppliers are listed for this compound. 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. Twenty-four suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
Summary for 079139
| Tradename: | LITHIUM CARBONATE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | lithium carbonate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 079139
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | lithium carbonate | CAPSULE;ORAL | 079139 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8480 | 0615-8480-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8480-39) |
| LITHIUM CARBONATE | lithium carbonate | CAPSULE;ORAL | 079139 | ANDA | American Health Packaging | 60687-806 | 60687-806-01 | 100 BLISTER PACK in 1 CARTON (60687-806-01) / 1 CAPSULE in 1 BLISTER PACK (60687-806-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Feb 3, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Feb 3, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 600MG | ||||
| Approval Date: | Feb 3, 2009 | TE: | AB | RLD: | No | ||||
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