Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209798
Company: RISING
Company: RISING
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 | 076242 | HIKMA |
CALCITRIOL | CALCITRIOL | 1MCG/ML | SOLUTION;ORAL | Prescription | No | AA | 203973 | PATRIN |
CALCITRIOL | CALCITRIOL | 1MCG/ML | SOLUTION;ORAL | Prescription | No | AA | 209798 | RISING |
ROCALTROL | CALCITRIOL | 1MCG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 021068 | SS PHARMA |