Application 077036

Type: ANDA
Sponsor: EPIC PHARMA LLC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077036-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28
A077036-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28
A077036-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077036-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077036-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077036-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-10-28	`301d65b070ca…`

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	2500cc9d-a67d-46c5-9a76-99bc63959d67	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	15cb00da-4435-4930-90d0-faadf2739a5c	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	05421bee-f746-418e-bb9c-ab44a89b567d	2024-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	b244d4eb-8311-4663-8bca-dc08e88e5f5d	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
CITALOPRAM HYDROBROMIDE	CITALOPRAM	Exelan Pharmaceuticals Inc.	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	2024-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals, Inc.	4f45c818-b324-6ca6-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	579836d8-64ed-de2d-e053-2a91aa0a8392	2024-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	549a5b3f-4928-1ae5-e054-00144ff8d46c	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	e0822069-9672-4d4c-bc1a-8739b0dd045c	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	9987a273-e6d7-54cd-e053-2a95a90a0aaa	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Aurobindo Pharma Limited	2632b547-2e13-447f-ac85-c774e437d6a8	2024-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Aurobindo Pharma Limited	e7a2cbdd-1bdb-4e59-a3dd-298a189753ae	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	fc766b76-18c1-42cd-b276-f720f5821c11	2024-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Camber Pharmaceuticals, Inc.	dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	c6730edc-7226-4521-a04a-1bf296b01b8d	2024-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	9059c8f1-8755-492d-aba2-5f5088ce69d3	2023-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	9d2f8f9f-9710-48e0-bc18-105a2af1073b	2023-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	fd761647-e16b-45b3-a4bc-364de0ed7015	2023-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	4eb71151-241a-476e-a495-4a021bc55bda	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram Hydrobromide generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	f37cc307-8b7d-4e5c-8beb-cd8779bc86a7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44331	ORIG	2005-07-29
31188	ORIG	2004-10-29