Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021068
Company: ESJAY PHARMA

Products on NDA 21068

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROCALTROL	CALCITRIOL	1MCG/ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Labels for NDA 021068

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