Orange Book product · Generic (ANDA)
FLUOXETINE HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE
At a glance
Feb 07, 2002
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 07, 2002
24 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOXETINE HYDROCHLORIDE
Strength
EQ 20MG BASE/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 075292
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUOXETINE HYDROCHLORIDE
- 2001PROZAC WEEKLYBrand (NDA)
NDA 021235 · LILLY
- 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
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.

