Visitor Monitoring Drug History: REQUIP
 
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: REQUIP
FDA Application No: (NDA) 020658
Active Ingredient(s): ROPINIROLE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on May 17, 2005 for REQUIP, (NDA) 020658


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/4/2005 013New or Modified Indication Letter
Label 
6/19/2003 012Labeling Revision Letter
Review 
10/22/2002 011Package Change  
7/5/2001 010Expiration Date Change  
4/3/2001 009Control Supplement  
3/1/2001 008Manufacturing Change or Addition  
5/15/2000 007Labeling Revision  
11/2/1999 006Package Change  
8/16/1999 005Manufacturing Change or Addition  
5/15/2000 003Labeling Revision  
1/27/1999 001Manufacturing Change or Addition  
9/19/1997 000Approval Review 
 
There are no Therapeutic Equivalents
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