Details for New Drug Application (NDA): 076691
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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 076691
Tradename: | LITHIUM CARBONATE |
Applicant: | Hikma |
Ingredient: | lithium carbonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076691
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LITHIUM CARBONATE | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 076691 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0020 | 0054-0020-25 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0020-25) |
LITHIUM CARBONATE | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 076691 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-901 | 43063-901-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-901-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 450MG | ||||
Approval Date: | Jan 5, 2004 | TE: | AB | RLD: | No |
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