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ROCALTROL (nda018044)- (0.25MCG,0.5MCG)

CALCITRIOL ESJAY PHARMA
0.25MCG,0.5MCG
No No
2000-Jul-05 Expired
None None
None No
*Predialysis Patients: Rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. *Dialysis Patients: Rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. *Hypoparathyroidism Patients: Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
6 0 6
Total Other Developers None
Drugs with Suitability No
0.25MCG ** ** - - 5
0.5MCG ** ** - - 4
NDA Sales Available Total Generic Sales Available
Yes 5
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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