Details for New Drug Application (NDA): 017812
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The generic ingredient in LITHIUM CARBONATE is lithium carbonate. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
Summary for 017812
Tradename: | LITHIUM CARBONATE |
Applicant: | Hikma |
Ingredient: | lithium carbonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 017812
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LITHIUM CARBONATE | lithium carbonate | CAPSULE;ORAL | 017812 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-2526 | 0054-2526-25 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2526-25) |
LITHIUM CARBONATE | lithium carbonate | CAPSULE;ORAL | 017812 | NDA | Hikma Pharmaceuticals USA Inc. | 0054-2527 | 0054-2527-25 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2527-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
Approval Date: | Jan 28, 1987 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 600MG | ||||
Approval Date: | Jan 28, 1987 | TE: | AB | RLD: | Yes |
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