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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018936

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PROZAC (FLUOXETINE HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: PROZAC
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N018936
Product Number: 006
Approval Date: Dec 23, 1992
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information
PROZAC (FLUOXETINE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: PROZAC
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N018936
Product Number: 001
Approval Date: Dec 29, 1987
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information
PROZAC (FLUOXETINE HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: PROZAC
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N018936
Product Number: 003
Approval Date: Jun 15, 1999
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information
PROZAC (FLUOXETINE HYDROCHLORIDE)
EQ 60MG BASE
Marketing Status: Discontinued
Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: PROZAC
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018936
Product Number: 004
Approval Date: Jun 15, 1999
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
SARAFEM (FLUOXETINE HYDROCHLORIDE)
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: SARAFEM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018936
Product Number: 007
Approval Date: Jul 6, 2000
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
SARAFEM (FLUOXETINE HYDROCHLORIDE)
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: SARAFEM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018936
Product Number: 008
Approval Date: Jul 6, 2000
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
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