Orange Book product · Generic (ANDA)
PAROXETINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE
At a glance
Sep 03, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 03, 2021
4 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
PAROXETINE HYDROCHLORIDE
Strength
EQ 10MG BASE/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 215003
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of PAROXETINE HYDROCHLORIDE
- 1999PAXIL CRBrand (NDA)
NDA 020936 · APOTEX
- 1998PAXILBrand (NDA)
NDA 020885 · APOTEX
- 1997PAXILBrand (NDA)
NDA 020710 · APOTEX
- 1992PAXILBrand (NDA)
NDA 020031 · APOTEX
- 2026PAROXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217280 · ALEMBIC
- 2026PAROXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219954 · ANNORA PHARMA
- 2024PAROXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209748 · PRINSTON INC
- 2021PAROXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211248 · YILING
- 2021PAROXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212645 · CADILA PHARMS LTD
- 2021PAROXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213612 · EPIC PHARMA LLC
- 2021PAROXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213485 · CSPC OUYI
- 2018PAROXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209293 · SCIECURE PHARMA INC
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.
