Orange Book product · Brand (NDA)
CELEXA
CITALOPRAM HYDROBROMIDE
At a glance
Apr 27, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 27, 2000
26 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
CITALOPRAM HYDROBROMIDE
Strength
EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020822
Product number
001
Marketing status
RX
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.
- 2022CITALOPRAM HYDROBROMIDEBrand (NDA)
NDA 215428 · ALMATICA
- 2005CITALOPRAM HYDROBROMIDEBrand (NDA)
NDA 021763 · BIOVAIL LABS INTL
- 1999CELEXABrand (NDA)
NDA 021046 · FOREST LABS
- 2026CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 219985 · AUROBINDO PHARMA LTD
- 2015CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 205407 · JUBILANT GENERICS
- 2015CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 201450 · HETERO LABS LTD III
- 2009CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 077654 · GLENMARK PHARMS LTD
- 2008CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 077141 · NATCO PHARMA LTD
- 2007CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 078216 · TORRENT PHARMS
- 2007CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 077668 · PHARMOBEDIENT
- 2006CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 077289 · AMNEAL PHARMS NY
- 2006CITALOPRAM HYDROBROMIDEGeneric (ANDA)
ANDA 077534 · INVAGEN 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.
