Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209798
Company: ELYSIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCITRIOL CALCITRIOL 1MCG/ML SOLUTION;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/21/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CALCITRIOL

SOLUTION;ORAL; 1MCG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCITRIOL CALCITRIOL 1MCG/ML SOLUTION;ORAL Prescription No AA 209798 ELYSIUM
CALCITRIOL CALCITRIOL 1MCG/ML SOLUTION;ORAL Prescription No AA 076242 HIKMA
ROCALTROL CALCITRIOL 1MCG/ML SOLUTION;ORAL Prescription Yes AA 021068 VALIDUS PHARMS

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