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`Drug Details
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`Drug Name(s)
`FDA Application No.
`Active Ingredient(s)
`Company
`Original Approval or Tentative Approval Date
`Chemical Type
`Review Classification
`
`PROZAC
`(NDA) 018936
`FLUOXETINE HYDROCHLORIDE
`ELI LILLY AND CO
`December 29, 1987
`1 New molecular entity (NME)
`P Priority review drug
`
`(cid:122) Therapeutic Equivalents
`
`(cid:122) Label Information
`
`(cid:122) Approval History, Letters, Reviews, and
`Related Documents
`
`(cid:122) Medication Guide11
`
`Products on Application (NDA) #018936
` Click on a column header to re-sort the table:
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`(cid:122) Other Important Information from FDA 10
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`Active Ingredients Strength
`
`Drug
`Name
`PROZAC FLUOXETINE
`HYDROCHLORIDE
`PROZAC FLUOXETINE
`HYDROCHLORIDE
`PROZAC FLUOXETINE
`HYDROCHLORIDE
`PROZAC FLUOXETINE
`HYDROCHLORIDE
`SARAFEM FLUOXETINE
`HYDROCHLORIDE
`
`SARAFEM FLUOXETINE
`HYDROCHLORIDE
`
`EQ 20MG BASE
`
`EQ 40MG BASE
`
`EQ 60MG BASE
`
`EQ 10MG BASE
`
`EQ 10MG BASE **Federal Register determination
`that product was not discontinued or withdrawn
`for safety or efficacy reasons**
`EQ 20MG BASE **Federal Register determination
`that product was not discontinued or withdrawn
`for safety or efficacy reasons**
`
`RLDTE
`Marketing
`Dosage
`Status
`Code
`Form/Route
`CAPSULE;ORAL Prescription No AB1
`
`CAPSULE;ORAL Prescription Yes AB
`
`CAPSULE;ORAL Discontinued No None
`
`CAPSULE;ORAL Prescription No AB1
`
`CAPSULE;ORAL Discontinued No None
`
`CAPSULE;ORAL Discontinued No None
`
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`Exhibit 1018
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`2/23/2016
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`Roxane Labs., Inc.
`Exhibit 1018
`Page 002