Application 077048

Type: ANDA
Sponsor: ACP NIMBLE

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
A077048-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16
A077048-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16
A077048-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16

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	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077048-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2004-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077048-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2004-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077048-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2004-11-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077048-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077048-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077048-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077048-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077048-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077048-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077048-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077048-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077048-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077048-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077048-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077048-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077048-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077048-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077048-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077048-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077048-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077048-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077048-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077048-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077048-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077048-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077048-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077048-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077048-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077048-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077048-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077048-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077048-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077048-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077048-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077048-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077048-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077048-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077048-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077048-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077048-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077048-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077048-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077048-001	AB	1	`6a51e52b5d6a…`

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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM HYDROBROMIDE	Aphena Pharma Solutions - Tennessee, LLC	31ddd184-7560-473c-b674-5fa3187c5598	2020-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	289c1d5e-902f-47db-85b8-5e1a55ec8684	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
CITALOPRAM HYDROBROMIDE	CITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	d05f4e71-95f3-4f22-8b01-b21e5c19e0f2	2018-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CITALOPRAM HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-6510	Citalopram	Citalopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6511	Citalopram	Citalopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6512	Citalopram	Citalopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0713-4740	Citalopram	Citalopram Tablets	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-4740	Citalopram	Citalopram Tablets	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-4740	Citalopram	Citalopram Tablets	G&W Laboratories, Inc.	ANDA	Current
0713-4740	Citalopram	Citalopram Tablets	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-4741	Citalopram	Citalopram Tablet	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-4741	Citalopram	Citalopram Tablet	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-4741	Citalopram	Citalopram Tablet	G&W Laboratories, Inc.	ANDA	Current
0713-4741	Citalopram	Citalopram Tablet	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-4742	Citalopram	Citalopram Tablet	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-4742	Citalopram	Citalopram Tablet	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-4742	Citalopram	Citalopram Tablet	G&W Laboratories, Inc.	ANDA	Current
0713-4742	Citalopram	Citalopram Tablet	Cosette Pharmaceuticals, Inc.	ANDA	Current
10544-149	Citalopram	Citalopram	Blenheim Pharmacal, Inc.	ANDA	Current
10544-150	Citalopram	Citalopram	Blenheim Pharmacal, Inc.	ANDA	Current
53808-0976	Citalopram	Citalopram	State of Florida DOH Central Pharmacy	ANDA	Current
66116-329	Citalopram	Citalopram	MedVantx, Inc.	ANDA	Current
66116-445	Citalopram	Citalopram	MedVantx, Inc.	ANDA	Current
66116-455	Citalopram	Citalopram	MedVantx, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44336	ORIG	2005-07-29