Application 021763

Type: NDA
Sponsor: BIOVAIL LABS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 10MG BASE	No	No
002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 20MG BASE	No	No
003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 40MG BASE	No	No
004	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	TABLET; ORALLY DISINTEGRATING	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021763-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20
N021763-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20
N021763-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021763-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021763-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021763-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-12-20	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Preferred Pharmaceuticals Inc.	27ddea53-f03d-4760-99bb-ec8efa44ff62	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	REMEDYREPACK INC.	625a78b2-4751-4ca5-91b6-7c85fd9f8c2e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
CITALOPRAM HYDROBROMIDE	CITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	7307df53-d570-4e26-971d-e97522ccce7f	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Preferred Pharmaceuticals, Inc.	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	d9cc1649-913d-832d-e053-2995a90a5f9a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	d9ccb3fb-b607-9491-e053-2995a90a39c9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	c133fc77-6c8a-d2b1-e053-2995a90ab5f7	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	QPharma, Inc.	0a967468-3869-4c8c-849f-9fc3a8dcc489	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	PD-Rx Pharmaceuticals, Inc.	31a18cdf-b0aa-18f5-e054-00144ff8d46c	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	544ba802-a536-579a-e054-00144ff88e88	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea52	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	ATLANTIC BIOLOGICALS CORP.	2640311d-8b88-4513-9c80-a08390b8142a	2025-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	REMEDYREPACK INC.	0109f365-bebd-4810-a56f-4451e10245db	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	c577b306-ee7c-8364-e053-2a95a90abb13	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	c584909b-e7b2-7108-e053-2995a90a2f54	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8b06b55-f6a2-2438-e053-6394a90a530a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Quality Care Products, LLC	6fc110ba-87e7-404e-9e00-b680f354c7b0	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Quality Care Products, LLC	e22fe468-5d9e-4ec7-a69b-4988e0b8acbd	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	8719bd44-36b6-468d-9203-8c53a2645184	2024-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	1a136cc3-d655-4f3c-8710-2603dc008492	2024-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
21808	ORIG	2007-09-10
28549	ORIG	2006-01-19
37605	ORIG	2006-01-06