Product Details for NDA 020974
PROZAC (FLUOXETINE HYDROCHLORIDE)
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PROZAC
Dosage Form; Route of Administration: TABLET; 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Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020974
Product Number: 001
Approval Date: Mar 9, 1999
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information
PROZAC (FLUOXETINE HYDROCHLORIDE)
Proprietary Name: PROZAC
Dosage Form; Route of Administration: TABLET; 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Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020974
Product Number: 001
Approval Date: Mar 9, 1999
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PROZAC
Dosage Form; Route of Administration: TABLET; 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Strength: EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020974
Product Number: 002
Approval Date: Mar 9, 1999
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PROZAC
Dosage Form; Route of Administration: TABLET; 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Strength: EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020974
Product Number: 002
Approval Date: Mar 9, 1999
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information