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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "018936."



Active Ingredient: FLUOXETINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: PROZAC
Applicant: ELI LILLY AND CO
Strength: EQ 20MG BASE
Application Number: N018936
Product Number: 001
Approval Date: Dec 29, 1987
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: FLUOXETINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: PROZAC
Applicant: ELI LILLY AND CO
Strength: EQ 40MG BASE
Application Number: N018936
Product Number: 003
Approval Date: Jun 15, 1999
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: FLUOXETINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: PROZAC
Applicant: ELI LILLY AND CO
Strength: EQ 10MG BASE
Application Number: N018936
Product Number: 006
Approval Date: Dec 23, 1992
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB1
Patent and Exclusivity Info for this product: View

Active Ingredient: FLUOXETINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: SARAFEM
Applicant: ELI LILLY AND CO
Strength: EQ 10MG BASE
Application Number: N018936
Product Number: 007
Approval Date: Jul 6, 2000
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB2
Patent and Exclusivity Info for this product: View

Active Ingredient: FLUOXETINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: SARAFEM
Applicant: ELI LILLY AND CO
Strength: EQ 20MG BASE
Application Number: N018936
Product Number: 008
Approval Date: Jul 6, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB2
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through September 2014
Patent and Generic Drug Product Data Last Updated October 30, 2014

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