Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021068
Company: VALIDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROCALTROL CALCITRIOL 1MCG/ML SOLUTION;ORAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/20/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21068ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/021068.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/15/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/07/2004 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18044slr032,21068slr002ltr.pdf
02/01/2002 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21068s1ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/20/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21068lbl.pdf

ROCALTROL

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 INVATECH PHARMA
CALCITRIOL CALCITRIOL 1MCG/ML SOLUTION;ORAL Prescription No AA 076242 WEST-WARD PHARMS INT
ROCALTROL CALCITRIOL 1MCG/ML SOLUTION;ORAL Prescription Yes AA 021068 VALIDUS PHARMS

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