Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Calcitriol Capsule, Roxane Labs, Approval | Calcijex (calcitriol) Injection, Abbott Labs, Labeling Revision | Calcitriol Injection, Akorn Inc., Approval | Vectical (calcitriol) Ointment, Galderma Laboratories, L.P., Approval ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2009 Betterchem.com