Visitor Monitoring Drug Details: RESTORIL
 
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Drug Details

Drug Name: RESTORIL
FDA Application No: (NDA) 018163
Active Ingredient(s): TEMAZEPAM
Company: TYCO HLTHCARE
Original Approval or Tentative Approval Date: February 27, 1981
Chemical Type: 1 New molecular entity (NME)
Review Classification: S Standard review drug
 
Therapeutic Equivalents Labels are not available
Approval History, Letters, Reviews and Related Documents
 
You can see the products in the same application. The table can be sorted by clicking the header columns.
 
Drug NameSort imageActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE Code
RESTORIL TEMAZEPAM15MGCAPSULE; ORAL Prescription No AB
RESTORIL TEMAZEPAM30MGCAPSULE; ORAL Prescription Yes AB
RESTORIL TEMAZEPAM7.5MGCAPSULE; ORAL Prescription No None
RESTORIL TEMAZEPAM22.5MGCAPSULE; ORAL Prescription No None


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