RecallHawk

PROZAC (FLUOXETINE HYDROCHLORIDE)

ELI LILLY AND CO

Summary

FDA approved PROZAC (FLUOXETINE HYDROCHLORIDE) by ELI LILLY AND CO. NDA (New Drug) approval (Labeling) on 2023-08-18. CAPSULE, ORAL.

Details

Source

Drug Approval

External ID

NDA018936-112

Action Date

2023-08-18

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

PROZAC (generic: FLUOXETINE HYDROCHLORIDE), CAPSULE, ORAL. Application: NDA018936

Context & Analysis

ELI LILLY AND CO has 12 FDA actions in our database.

Frequently Asked Questions

How often does ELI LILLY AND CO have FDA actions?

ELI LILLY AND CO has 12 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA018936-112" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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