Details for New Drug Application (NDA): 091616
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NDA 091616 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 091616
| Tradename: | LITHIUM CARBONATE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | lithium carbonate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091616
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 091616 | ANDA | AvKARE | 42291-496 | 42291-496-01 | 100 TABLET in 1 BOTTLE (42291-496-01) |
| LITHIUM CARBONATE | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 091616 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-224 | 68462-224-01 | 100 TABLET in 1 BOTTLE (68462-224-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 450MG | ||||
| Approval Date: | Feb 14, 2011 | TE: | AB | RLD: | No | ||||
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