Visitor Monitoring Drug History: ROCALTROL
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: ROCALTROL
FDA Application No: (NDA) 018044
Active Ingredient(s): CALCITRIOL
Company: ROCHE
 
Label History
 
Labels are not available on this site for ROCALTROL, (NDA) 018044
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/7/2004 032Labeling Revision Letter 
11/12/2001 030Package Change  
10/15/2001 029Manufacturing Change or Addition  
2/1/2002 028Labeling Revision Letter 
12/15/2000 027Control Supplement  
4/27/1999 026Manufacturing Change or Addition  
11/20/1998 025New or Modified Indication Letter 
10/22/1996 024Labeling Revision Review 
5/26/1995 023Control Supplement  
12/15/1995 022Control Supplement  
9/24/1993 021Control Supplement  
9/24/1991 020Control Supplement  
3/13/1990 019Control Supplement Review 
4/8/1991 018Labeling Revision Review 
4/27/1988 017Labeling Revision  
4/27/1988 016Control Supplement  
5/16/1986 015Labeling Revision  
12/20/1985 014Manufacturing Change or Addition  
1/22/1986 012General Efficacy (MarkIV)  
8/20/1984 011Package Change  
9/16/1986 010Control Supplement  
11/4/1983 009Labeling Revision  
4/22/1982 008Labeling Revision  
12/10/1980 006Control Supplement  
5/12/1980 005Manufacturing Change or Addition  
11/9/1979 002Control Supplement  
12/6/1978 001Control Supplement  
8/17/1978 000Approval  
 
Therapeutic Equivalents
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