FDA Orange Book · active-ingredient family
Citalopram hydrobromide
Citalopram hydrobromide is approved as 4 brand and 33 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CITALOPRAM HYDROBROMIDE · NDA 215428
4
Brand (NDA)
33
Generics (ANDA)
0
Listed patents
1
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CITALOPRAM HYDROBROMIDERLD | ALMATICA | NDA 215428 | AB | Jan 31, 2022 | |
| CITALOPRAM HYDROBROMIDERLD×3 | BIOVAIL LABS INTL | NDA 021763 | — | Dec 20, 2005 | |
| CELEXARLD×4 | ABBVIE | NDA 020822 | AB | Apr 27, 2000 | |
| CELEXARLD | FOREST LABS | NDA 021046 | — | Dec 22, 1999 |
Generic (ANDA) products (33)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CITALOPRAM HYDROBROMIDE | AUROBINDO PHARMA LTD | ANDA 219985 | AB | Mar 13, 2026 | |
| CITALOPRAM HYDROBROMIDE×3 | JUBILANT GENERICS | ANDA 205407 | — | Dec 23, 2015 | |
| CITALOPRAM HYDROBROMIDE | HETERO LABS LTD III | ANDA 201450 | AA | Dec 15, 2015 | |
| CITALOPRAM HYDROBROMIDE×3 | GLENMARK PHARMS LTD | ANDA 077654 | — | Feb 27, 2009 | |
| CITALOPRAM HYDROBROMIDE×2 | NATCO PHARMA LTD | ANDA 077141 | — | Apr 10, 2008 | |
| CITALOPRAM HYDROBROMIDE×3 | TORRENT PHARMS | ANDA 078216 | AB | Mar 27, 2007 | |
| CITALOPRAM HYDROBROMIDE×3 | PHARMOBEDIENT | ANDA 077668 | — | Feb 28, 2007 | |
| CITALOPRAM HYDROBROMIDE×3 | AMNEAL PHARMS NY | ANDA 077289 | — | Nov 30, 2006 | |
| CITALOPRAM HYDROBROMIDE×3 | INVAGEN PHARMS | ANDA 077534 | AB | Oct 03, 2006 | |
| CITALOPRAM HYDROBROMIDE | AUROBINDO PHARMA | ANDA 077812 | AA | Aug 28, 2006 | |
| CITALOPRAM HYDROBROMIDE×3 | SUN PHARM INDUSTRIES | ANDA 077052 | — | Jul 03, 2006 | |
| CITALOPRAM HYDROBROMIDE | CHARTWELL MOLECULAR | ANDA 077629 | AA | Jun 14, 2006 | |
| CITALOPRAM HYDROBROMIDE×3 | HERITAGE PHARMA | ANDA 077213 | — | Mar 31, 2006 | |
| CITALOPRAM HYDROBROMIDE×3 | TARO | ANDA 077278 | — | Mar 22, 2006 | |
| CITALOPRAM HYDROBROMIDE | PHARM ASSOC | ANDA 077601 | — | Nov 15, 2005 | |
| CITALOPRAM HYDROBROMIDE×3 | HERITAGE PHARMA | ANDA 077232 | — | Oct 31, 2005 | |
| CITALOPRAM HYDROBROMIDE×3 | CHARTWELL RX | ANDA 077040 | — | Aug 17, 2005 | |
| CITALOPRAM HYDROBROMIDE×3 | HERITAGE PHARMA | ANDA 077034 | — | Jun 30, 2005 | |
| CITALOPRAM HYDROBROMIDE×3 | EPIC PHARMA | ANDA 077045 | AB | Apr 29, 2005 | |
| CITALOPRAM HYDROBROMIDE×3 | PHARMOBEDIENT | ANDA 077039 | — | Feb 03, 2005 | |
| CITALOPRAM HYDROBROMIDE | HIKMA | ANDA 077043 | AA | Dec 13, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | APOTEX | ANDA 077046 | — | Nov 24, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | ROXANE | ANDA 077041 | — | Nov 23, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | COSETTE PHARMS NC | ANDA 077048 | — | Nov 16, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | SUN PHARM INDS INC | ANDA 077032 | — | Nov 12, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | CHARTWELL MOLECULAR | ANDA 077044 | AB | Nov 05, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | MYLAN | ANDA 077042 | AB | Nov 05, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | PHARMOBEDIENT | ANDA 077037 | — | Nov 05, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | AUROBINDO | ANDA 077031 | AB | Oct 28, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | DR REDDYS LABS LTD | ANDA 077038 | AB | Oct 28, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | EPIC PHARMA LLC | ANDA 077036 | — | Oct 28, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | FOSUN PHARMA | ANDA 077035 | — | Oct 28, 2004 | |
| CITALOPRAM HYDROBROMIDE×3 | HERITAGE PHARMA | ANDA 077033 | — | Oct 28, 2004 |
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Sep 16, 2026
in 3 mo
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.
Citalopram hydrobromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
