Application 077042

Type: ANDA
Sponsor: MYLAN

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 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	TE codes	Approval date
A077042-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05
A077042-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05
A077042-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077042-001	AB
A077042-002	AB
A077042-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077042-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-11-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077042-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077042-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077042-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077042-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077042-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077042-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077042-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077042-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077042-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077042-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077042-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077042-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077042-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077042-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077042-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077042-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077042-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077042-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077042-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077042-001	AB	1	`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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM	REMEDYREPACK INC.	f79f878e-99fb-4757-8abb-931af1fa9e2b	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042 ndc (product): 70518-2553
Citalopram	CITALOPRAM	REMEDYREPACK INC.	aa9c1440-354f-43a6-9e70-fd7bafcb03c5	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042 ndc (product): 70518-2601
Citalopram	CITALOPRAM	Bryant Ranch Prepack	2a8acad8-0ba0-4631-9f6d-f587e7a8558c	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042
Citalopram	CITALOPRAM	Mylan Pharmaceuticals Inc.	825c0c49-5fbf-6d8b-cb8c-94ebf0eda043	2024-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042 ndc (product): 0378-6231 ndc (product): 0378-6232 ndc (product): 0378-6233
Citalopram	CITALOPRAM	NuCare Pharmaceuticals,Inc.	0dfb11d9-f48d-56ee-e063-6294a90ad256	2024-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077042 application number: ANDA077042

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6231	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6231	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6231	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6231	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6232	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6232	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6232	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6232	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6233	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6233	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6233	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6233	Citalopram	citalopram	Mylan Pharmaceuticals Inc.	ANDA	Current
53808-0226	Citalopram	citalopram	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0647	Citalopram	citalopram	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0906	Citalopram	citalopram	State of Florida DOH Central Pharmacy	ANDA	Current
63629-6691	Citalopram	citalopram	Bryant Ranch Prepack	ANDA	Current
63629-6691	Citalopram	citalopram	Bryant Ranch Prepack	ANDA	Current
67046-101	Citalopram	citalopram	Contract Pharmacy Services-PA	ANDA	Current
67046-101	Citalopram	citalopram	Contract Pharmacy Services-PA	ANDA	Current
67046-102	Citalopram	citalopram	Contract Pharmacy Services-PA	ANDA	Current
67046-102	Citalopram	citalopram	Contract Pharmacy Services-PA	ANDA	Current
67046-106	Citalopram	citalopram	Contract Pharmacy Services-PA	ANDA	Current
67046-106	Citalopram	citalopram	Contract Pharmacy Services-PA	ANDA	Current
67046-111	Perrigo Citalopram	Citalopram	Contract Pharmacy Services-PA	ANDA	Current
70518-0449	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0449	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0449	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0449	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0449	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0561	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0561	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0561	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0561	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0561	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-0561	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2553	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2553	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2553	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2601	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2601	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2601	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2671	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2671	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current
70518-2671	Citalopram	citalopram	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23852	ORIG	2005-07-29