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FDA Approval Activities for this Drug…
Cyclosporine Capsules USP , (Modified), 25 mg and 200 mg, Sidmak , ANDA 65-044 12/20/00 2/27/01 Cyclosporine Capsules USP, 25 mg and 100 mg, Torpharm ANDA 65-040 5/9/02 4/9/03 Cyclosporine Capsules USP , (Modified), 25 mg and 100 mg, Eon Labs Manufacturing ANDA 65-017 1/13/00 1/24/00 6/7/01 Cyclosporine Capsules USP , (Modified), 25 mg, 50 mg and 100 mg, Abbott ANDA 65-003 5/12/00 5/22/00 8/4/03 Cyclosporine Injection USP, 50 mg/mL, Pharmaforce ANDA 65-151 10/7/03 Cyclosporine Injection USP, 50 mg/mL, Bedford ANDA 65-004 10/29/99 12/30/99 Cyclosporine Solution USP (modified),100mg/mL, Abbott ANDA 65-025 3/3/00 3/7/00 6/7/01 Cyclosporine Solution USP (Modified), 100 mg/mL, Sidmak , ANDA 65-054 Neoral (cyclosporine) Soft Gelatin Capsules USP, MODIFIED, 25 mg, 100 mg, Novartis NDA 50-715/S-010, S-014 & 50-716/S-014, S-018 Restasis (cyclosporine) Ophthalmic Emulsion, 0.05%, Allergan, NDA 50-790/S3 & S4 10/1/03 10/10/03 Restasis (cyclosporine) Ophthalmic Emulsion, 0.05%, Allergan, NDA 50-790/S1 9/16/03 9/25/03 9/26/03 Restasis (cyclosporine) Ophthalmic Emulsion, 0.05%, Allergan, NDA 50-790 Sandimmune (cyclosporine) Intravenous, Solution & Soft Gelatin Capsules, 50 mg/mL, 100 mg/mL & 25, 50, and 100 mg, respectively Novartis NDA 50-573/S21 & S23, 50-574/S-027 & S29 & 50-625/S30 & S32 SangCya Cyclosporine Solution, USP [Modified], 100 mg/mL, Sangstat Medical ANDA 64-195 CYCLOSPORINE Capsule; 100MG GENGRAF Abbott 065003 AB1 CYCLOSPORINE Capsule; 25MG GENGRAF Abbott 065003 BX CYCLOSPORINE Capsule; 50MG GENGRAF Abbott 065017 AB1 CYCLOSPORINE Capsule; 100MG CYCLOSPORINE Eon 065017 AB1 CYCLOSPORINE Capsule; 25MG CYCLOSPORINE Eon 050715 AB1 CYCLOSPORINE Capsule; 100MG NEORAL NOVARTIS 050625 AB2 CYCLOSPORINE Capsule; 100MG SANDIMMUNE NOVARTIS 050625 AB2 CYCLOSPORINE Capsule; 25MG SANDIMMUNE NOVARTIS 050715 AB1 CYCLOSPORINE Capsule; 25MG NEORAL NOVARTIS 050625 BX CYCLOSPORINE Capsule; 50MG SANDIMMUNE NOVARTIS 065044 AB1 CYCLOSPORINE Capsule; 100MG CYCLOSPORINE Pliva 065044 AB1 CYCLOSPORINE Capsule; 25MG CYCLOSPORINE Pliva 065040 AB2 CYCLOSPORINE Capsule; 100MG CYCLOSPORINE Torpharm 065040 AB2 CYCLOSPORINE Capsule; 25MG CYCLOSPORINE Torpharm 050790 CYCLOSPORINE Emulsion; Ophthalmic 0.05% RESTASIS ALLERGAN 065004 CYCLOSPORINE Injection 50MG/ML CYCLOSPORINE Bedford 050573 CYCLOSPORINE Injection 50MG/ML SANDIMMUNE NOVARTIS 065025 CYCLOSPORINE Solution; 100MG/ML CYCLOSPORINE Abbott 050716 CYCLOSPORINE Solution; 100MG/ML NEORAL NOVARTIS 050574 BX CYCLOSPORINE Solution; 100MG/ML SANDIMMUNE NOVARTIS 065054 CYCLOSPORINE Solution; 100MG/ML CYCLOSPORINE Pliva Sandimmune (cyclosporine) Intravenous, Oral Solution & Soft Gelatin Capsules, Novartis Pharmaceuticals Corporation | Cyclosporine Oral Solution, Morton Grove Pharma, Approval | Cyclosporine Oral Solution, Novex Pharma, Approval | Cyclosporine Oral Solution, IVAX Pharma, Approval | Cyclosporine Capsules, IVAX Pharmaceuticals, Approval | Neoral (Cyclosporine), Novartis Pharma, Labeling Revision | Neoral (Cyclosporine) Oral Solution, Novartis Pharma, Labeling Revision | Sandimmune (cyclosporine) Injection, Novartis Pharma. Labeling Revision | Sandimmune (cyclosporine) Oral Solution, Novartis Pharma. Labeling Revision | Sandimmune (cyclosporine) Soft Gel Capsules, Novartis Pharma. Labeling Revision | Neoral (cyclosporine) Soft Gelatin Capsules, Novartis Pharma, Labeling Revision | Neoral (cyclosporine) Oral Solution, Novartis Pharma, Labeling Revision | SANDIMMUNE (cyclosporine) Injection, Novartis Pharma, Labeling Revision | SANDIMMUNE (cyclosporine) Oral Solution, Novartis Pharma, Labeling Revision | SANDIMMUNE (cyclosporine) Soft-Gel Capsules, Novartis Pharma, Labeling Revision | Neoral (cyclosporine) Soft Gelatin Capsules, Novartis Pharma, Labeling Revision | Neoral (cyclosporine) Oral Solution, Novartis Pharma, Labeling Revision
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