FDA Orange Book · active-ingredient family
Citalopram hydrobromide
Citalopram hydrobromide: 4 brands, 33 generics; first approved Jul 17, 1998; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 33 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
4
Generics (ANDA)
33
Listed patents
0
Presentations
95
Brand (NDA) products
Originator applications
- CITALOPRAM HYDROBROMIDERLDRSALMATICANDA 2154282022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB - CITALOPRAM HYDROBROMIDERLDBIOVAIL LABS INTLNDA 02176320053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING ORAL Discontinued — EQ 20MG BASE TABLET, ORALLY DISINTEGRATING ORAL Discontinued — EQ 40MG BASE TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - CELEXARLDABBVIENDA 02082220004 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Discontinued — - CELEXARLDFOREST LABSNDA 0210461999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/5ML SOLUTION ORAL Discontinued —
Generic (ANDA) products (33)
Abbreviated applications
- CITALOPRAM HYDROBROMIDEAUROBINDO PHARMA LTDANDA 2199852026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE CAPSULE ORAL Rx AB - CITALOPRAM HYDROBROMIDEJUBILANT GENERICSANDA 20540720153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEHETERO LABS LTD IIIANDA 2014502015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/5ML SOLUTION ORAL Rx AA - CITALOPRAM HYDROBROMIDEGLENMARK PHARMS LTDANDA 07765420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDENATCO PHARMA LTDANDA 07714120082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDETORRENT PHARMSANDA 07821620073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - CITALOPRAM HYDROBROMIDEPHARMOBEDIENTANDA 07766820073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued — EQ 20MG BASE CAPSULE ORAL Discontinued — EQ 40MG BASE CAPSULE ORAL Discontinued — - CITALOPRAM HYDROBROMIDEAMNEAL PHARMS NYANDA 07728920063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEINVAGEN PHARMSANDA 07753420063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - CITALOPRAM HYDROBROMIDEAUROBINDO PHARMAANDA 0778122006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/5ML SOLUTION ORAL Rx AA - CITALOPRAM HYDROBROMIDESUN PHARM INDUSTRIESANDA 07705220063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDECHARTWELL MOLECULARANDA 0776292006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/5ML SOLUTION ORAL Rx AA - CITALOPRAM HYDROBROMIDEHERITAGE PHARMAANDA 07721320063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDETAROANDA 07727820063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEPHARM ASSOCANDA 0776012005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/5ML SOLUTION ORAL Discontinued — - CITALOPRAM HYDROBROMIDEHERITAGE PHARMAANDA 07723220053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDECHARTWELL RXANDA 07704020053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEHERITAGE PHARMAANDA 07703420053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEEPIC PHARMAANDA 07704520053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB - CITALOPRAM HYDROBROMIDEPHARMOBEDIENTANDA 07703920053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDERSHIKMAANDA 0770432004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/5ML SOLUTION ORAL Rx AA - CITALOPRAM HYDROBROMIDEAPOTEXANDA 07704620043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEROXANEANDA 07704120043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDECOSETTE PHARMS NCANDA 07704820043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDESUN PHARM INDS INCANDA 07703220043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDECHARTWELL MOLECULARANDA 07704420043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - CITALOPRAM HYDROBROMIDEMYLANANDA 07704220043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - CITALOPRAM HYDROBROMIDEPHARMOBEDIENTANDA 07703720043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEAUROBINDOANDA 07703120043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - CITALOPRAM HYDROBROMIDEDR REDDYS LABS LTDANDA 07703820043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - CITALOPRAM HYDROBROMIDEEPIC PHARMA LLCANDA 07703620043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEFOSUN PHARMAANDA 07703520043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — - CITALOPRAM HYDROBROMIDEHERITAGE PHARMAANDA 07703320043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- CGTFDA marketing exclusivity
in 21 d
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
28 yr 6 mo ago
Most recent approval
6 mo ago
Approvals span 1998–2026 across 37 FDA applications.
Brand (NDA) 411%
Generic (ANDA) 3389%
Citalopram hydrobromide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
