Visitor Monitoring Drug Details: PROZAC
 
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Drug Details

Drug Name: PROZAC
FDA Application No: (NDA) 018936
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
Company: LILLY
Original Approval or Tentative Approval Date: December 29, 1987
Chemical Type: 1 New molecular entity (NME)
Review Classification: P Priority review drug
 
Therapeutic Equivalents Label Information
Approval History, Letters, Reviews and Related Documents
 
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Drug NameSort imageActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE Code
PROZAC FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE; ORAL Prescription No AB
PROZAC FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE; ORAL Prescription Yes AB
PROZAC FLUOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE; ORAL Discontinued No None
PROZAC FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE; ORAL Prescription No AB
SARAFEM FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE; ORAL Prescription No None
SARAFEM FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE; ORAL Prescription Yes None


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