FDA — authorised 28 October 2004
- Application: ANDA077033
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 CITALOPRAM HYDROBROMIDE in United States
FDA authorised CITALOPRAM HYDROBROMIDE on 28 October 2004
Marketing authorisations
FDA — authorised 28 October 2004
- Application: ANDA077035
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2004
- Application: ANDA077031
- Marketing authorisation holder: AUROBINDO
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2004
- Application: ANDA077038
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2004
- Application: ANDA077036
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 2004
- Application: ANDA077037
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 2004
- Application: ANDA077044
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 2004
- Application: ANDA077042
- Marketing authorisation holder: MYLAN
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 2004
- Application: ANDA077032
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 2004
- Application: ANDA077048
- Marketing authorisation holder: COSETTE
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2004
- Application: ANDA077041
- Marketing authorisation holder: ROXANE
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 November 2004
- Application: ANDA077046
- Marketing authorisation holder: APOTEX
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2004
- Application: ANDA077043
- Marketing authorisation holder: HIKMA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 February 2005
- Application: ANDA077039
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 2005
- Application: ANDA077045
- Marketing authorisation holder: EPIC PHARMA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 2005
- Application: ANDA077034
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 2005
- Application: ANDA077040
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2005
- Application: ANDA077232
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 2005
- Application: NDA021763
- Marketing authorisation holder: BIOVAIL LABS INTL
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 31 March 2006
- Application: ANDA077213
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2006
- Application: ANDA077629
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 July 2006
- Application: ANDA077052
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2006
- Application: ANDA077812
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 October 2006
- Application: ANDA077534
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2007
- Application: ANDA077668
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 March 2007
- Application: ANDA078216
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 2008
- Application: ANDA077141
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2009
- Application: ANDA077654
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 December 2015
- Application: ANDA201450
- Marketing authorisation holder: HETERO LABS LTD III
- Status: supplemented
FDA — authorised 23 December 2015
- Application: ANDA205407
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2022
- Application: NDA215428
- Marketing authorisation holder: ALMATICA
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 March 2026
- Application: ANDA219985
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CITALOPRAM HYDROBROMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
CITALOPRAM HYDROBROMIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CITALOPRAM HYDROBROMIDE approved in United States?
Yes. FDA authorised it on 28 October 2004; FDA authorised it on 28 October 2004; FDA authorised it on 28 October 2004.
Who is the marketing authorisation holder for CITALOPRAM HYDROBROMIDE in United States?
HERITAGE PHARMA holds the US marketing authorisation.