Orange Book product · Brand (NDA)
PROZAC WEEKLY
FLUOXETINE HYDROCHLORIDE
At a glance
Feb 26, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 26, 2001
25 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOXETINE HYDROCHLORIDE
Strength
EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 021235
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1992PROZACBrand (NDA)
NDA 018936 · ELI LILLY AND CO
- 1991PROZACBrand (NDA)
NDA 020101 · LILLY
- 2022FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216953 · UPSHER SMITH LABS
- 2022FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216448 · NOVITIUM PHARMA
- 2022FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211444 · CHARTWELL RX
- 2022FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216232 · MICRO LABS
- 2020FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202729 · ACCORD HLTHCARE
- 2020FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213265 · AUROBINDO PHARMA LTD
- 2020FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213286 · AUROBINDO PHARMA LTD
- 2019FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206993 · CADILA PHARMS LTD
- 2017FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208698 · ALEMBIC
- 2015FLUOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204597 · SCIEGEN PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
