FDA Approval Activities for this Drug…

Calctriol Capsules, 0.25 mcg and 0.5 mcg, Teva USA ANDA 75-765 10/12/01 4/15/03 Calcitriol Injection, 0.001 mg/mL, Lyne ANDA 76-206 9/17/03 Calcitriol Injection, 0.001 mg/mL, Lyne ANDA 76-206 8/22/03 Calcitriol Injection, 0.001 mg/mL & 0.002 mg/mL, American Pharmaceutical Partners, ANDA 75-836 12/31/02 Calcitriol Injection, 0.001 mg/mL & 0.002 mg/mL, Gensia Sicor ANDA 75-823 1/2/03 Calcitriol Injection, 0.001 mg/mL & 0.002 mg/mL, Faulding Pharmaceutical Co. ANDA 75-816 12/31/02 Calcitriol Injection, 0.001 mg/mL & 0.002 mg/mL, aaiPharma ANDA 75-766 2/20/03 Calcitriol Injection, 0.001 mg/mL & 0.002 mg/mL, Luitpold ANDA 75-746 9/26/03 Calcitriol Injection, 0.001 mg/mL & 0.002 mg/mL, Luitpold ANDA 75-746 1/12/03 Calcitriol Solution, 1 mcg/mL, Roxane ANDA 76-242 Rocaltrol (calcitriol) Capsules & Solution, Hoffmann-LaRoche NDA 18-044/S28 & 21-068/S1 2/1/02 4/17/02 Rocaltrol (calcitriol)1mcg/mL oral solution Hoffman LaRoche NDA 21-068 and 18-044/S-025 11/20/98 11/20/98 Rocaltrol (calcitriol) Solution (3S) Roche Biolscience NDA 21-068 11/20/98 11/23/98 11/23/98 7/4/99 Rocaltrol Indication: Indication is for the management of secondary hyperparathyroidism and resultant metabolic bone disease in predialysis (moderate to severe chronic renal failure) patients (adults, neonates, and older infants). CALCITRIOL Capsule; 0.25UGM ROCALTROL ROCHE 018044 CALCITRIOL Capsule; 0.5UGM ROCALTROL ROCHE 075765 CALCITRIOL Capsule; 0.25UGM CALCITRIOL Teva 075765 CALCITRIOL Capsule; 0.5UGM CALCITRIOL Teva 075766 CALCITRIOL Injection 0.001MG/ML CALCITRIOL AAIPHARMA 075766 CALCITRIOL Injection 0.002MG/ML CALCITRIOL AAIPHARMA 018874 CALCITRIOL Injection 0.001MG/ML CALCIJEX Abbott 018874 CALCITRIOL Injection 0.002MG/ML CALCIJEX Abbott 075836 CALCITRIOL Injection 0.001MG/ML CALCITRIOL AM PARTNERS 075836 CALCITRIOL Injection 0.002MG/ML CALCITRIOL AM PARTNERS 075823 CALCITRIOL Injection 0.001MG/ML CALCITRIOL Gensia Sicor 075823 CALCITRIOL Injection 0.002MG/ML CALCITRIOL Gensia Sicor 075746 CALCITRIOL Injection 0.001MG/ML CALCITRIOL LUITPOLD 075746 CALCITRIOL Injection 0.002MG/ML CALCITRIOL LUITPOLD 076206 CALCITRIOL Injection 0.001MG/ML CALCITRIOL Lyne 021068 CALCITRIOL Solution; 1UGM/ML ROCALTROL ROCHE 076242 CALCITRIOL Solution; 1UGM/ML CALCITRIOL Roxane Calcitriol Injection, Mayne Pharma Rocaltrol (calcitriol) Capsules, Hoffmann-La Roche Inc., Labeling Revision Rocaltrol (calcitriol) Oral Solution, Hoffmann-La Roche Inc., Labeling Revision

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