Details for New Drug Application (NDA): 079159
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NDA 079159 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 079159
| Tradename: | LITHIUM CARBONATE |
| Applicant: | Alembic Ltd |
| Ingredient: | lithium carbonate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 079159
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | lithium carbonate | CAPSULE;ORAL | 079159 | ANDA | Alembic Pharmaceuticals Limited | 46708-303 | 46708-303-30 | 30 CAPSULE in 1 BOTTLE (46708-303-30) |
| LITHIUM CARBONATE | lithium carbonate | CAPSULE;ORAL | 079159 | ANDA | Alembic Pharmaceuticals Limited | 46708-303 | 46708-303-31 | 100 CAPSULE in 1 BOTTLE (46708-303-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Jan 12, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jan 12, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 600MG | ||||
| Approval Date: | Jan 12, 2009 | TE: | AB | RLD: | No | ||||
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