Application 204028

Type: ANDA
Sponsor: CASI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	No	No
002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	No	No
003	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG 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
A204028-001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29
A204028-002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29
A204028-003	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204028-001	AB
A204028-002	AB
A204028-003	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 3 · 99 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	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204028-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204028-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204028-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A204028-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204028-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204028-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204028-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204028-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204028-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204028-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204028-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204028-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204028-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204028-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204028-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204028-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204028-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204028-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204028-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204028-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204028-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204028-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204028-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204028-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204028-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204028-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204028-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204028-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204028-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204028-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204028-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204028-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204028-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204028-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204028-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204028-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204028-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204028-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204028-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204028-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204028-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204028-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204028-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DESVENLAFAXINE	DESVENLAFAXINE	Bryant Ranch Prepack	65f4a870-aa91-4d05-a32d-a161295bcc17	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
DESVENLAFAXINE	DESVENLAFAXINE	Bryant Ranch Prepack	643bfe62-7885-4db4-9fff-5d8552b53d14	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
DESVENLAFAXINE	DESVENLAFAXINE	Preferred Pharmaceuticals Inc.	5a136b61-f734-43d5-86fc-059ff3b5342a	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
DESVENLAFAXINE	DESVENLAFAXINE	Advagen Pharma Ltd	ff837eb1-24c3-4c63-9b4b-c6b5935a9b47	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
DESVENLAFAXINE	DESVENLAFAXINE	A-S Medication Solutions	48d3a09e-850d-472d-8fb2-996a5167b16d	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
DESVENLAFAXINE	DESVENLAFAXINE	A-S Medication Solutions	b14695b4-c35e-4902-8144-d31d698b1c58	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
Desvenlafaxine ER	DESVENLAFAXINE ER	Direct_rx	1d86d1dc-d685-43aa-e063-6294a90a9907	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
DESVENLAFAXINE	DESVENLAFAXINE	NorthStar Rx LLC	3fcc0555-f9cf-4735-a0ef-830c50c390b8	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
DESVENLAFAXINE	DESVENLAFAXINE	NuCare Pharmaceuticals,Inc.	2dce1542-ead5-1b24-e063-6294a90a6df0	2025-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028
DESVENLAFAXINE	DESVENLAFAXINE	Bryant Ranch Prepack	5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a4	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204028 application number: ANDA204028

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32492	ORIG	2015-07-08