FDA Approval Activities for this Drug…

Eskalith (lithium carbonate) Capsules and Eskalith CR (lithium carbonate) Controlled Release Tablets, SmithKline Beecham NDA 16-860/S-073, 17-971/S-019 & 18-152/S-017 Lithium Carbonate Capsules & Syrup, Roxane, NDA 17-812/S23 & 18-421/ S21 1/31/03 2/12/03 Lithium Carbonate Capsules, USP, 150, 300 and 600 mg, Roxane, NDA 17-812/SCP-021 6/14/01 11/25/02 Lithium Carbonate Capsules & Lithium Citrate Syrup, Roxane, NDA 17-812/S-011, S-013, S-014, S-016 & S-017 & 18-421/S-011, S-013, S-014, S-015, S-016 11/26/01 2/12/02 Lithium Carbonate Capsules & Controlled Release Tablets, SmithKline Beecham NDA 16-860/S59, S65, S67, S68, S69, S72 & 18-152/S3, S8, S10, S12, S13, S16 5/8/02 5/16/02 Lithium Carbonate Tablets ER, 450 mg, Barr ANDA 76-366 8/21/03 Lithium Carbonate Capsules USP, 150 mg, West-ward Pharmaceutical Corp. ANDA 76-243/S1 2/24/03 Lithium Carbonate Capsules USP, 300 mg, West-ward Pharmaceutical Corp. ANDA 76-243 6/27/02 Lithium Carbonate Capsules USP, 300 mg, Able, ANDA 76-121 9/27/01 4/16/03 Lithium Carbonate Extended-Release Tablets USP, 300 mg, Able ANDA 76-382 4/21/03 Lithium Carbonate Extended-Release Tablets USP, 300 mg, Barr, ANDA 76-170 LITHIUM CARBONATE Capsule; 300MG LITHIUM CARBONATE Able 016860 LITHIUM CARBONATE Capsule; 300MG ESKALITH GLAXOSMITHKLINE 017812 LITHIUM CARBONATE Capsule; 150MG LITHIUM CARBONATE Roxane 017812 LITHIUM CARBONATE Capsule; 300MG LITHIUM CARBONATE Roxane 017812 LITHIUM CARBONATE Capsule; 600MG LITHIUM CARBONATE Roxane 076243 LITHIUM CARBONATE Capsule; 150MG LITHIUM CARBONATE West Ward 076243 LITHIUM CARBONATE Capsule; 300MG LITHIUM CARBONATE West Ward 076382 LITHIUM CARBONATE Tablet, Extended Release; 300MG LITHIUM CARBONATE Able 076170 LITHIUM CARBONATE Tablet, Extended Release; 300MG LITHIUM CARBONATE Barr 076366 LITHIUM CARBONATE Tablet, Extended Release; 450MG LITHIUM CARBONATE Barr 018152 LITHIUM CARBONATE Tablet, Extended Release; 450MG ESKALITH CR GLAXOSMITHKLINE 018027 LITHIUM CARBONATE Tablet, Extended Release; 300MG LITHOBID SOLVAY 076490 LITHIUM CARBONATE Tablet, Extended Release; 450MG LITHIUM CARBONATE West Ward 016834 LITHIUM CARBONATE Tablet; 300MG LITHIUM CARBONATE PFIZER 018558 LITHIUM CARBONATE Tablet; 300MG LITHIUM CARBONATE Roxane 070755 LITHIUM CITRATE Syrup; 300MG CARBONATE/5ML LITHIUM CITRATE Morton Grove 018421 LITHIUM CITRATE Syrup; 300MG CARBONATE/5ML LITHIUM CITRATE Roxane Eskalith (lithium carbonate) Capsules, Tablets & CR Tablets, GlaxoSmithKline Lithium Carbonate Capsules, Able Laboratories, Inc. Approval | Lithium Carbonate Extended-Release Tablets, Roxane Labs, Approval | Lithium Carbonate Capsules, Apotex, Approval

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