Application 204082

Type: ANDA
Sponsor: HIKMA

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 25MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 76 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
2025-08-23 18:47 UTC	2025-08	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204082-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204082-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-28	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A204082-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204082-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204082-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204082-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204082-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204082-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204082-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204082-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204082-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204082-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204082-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204082-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204082-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204082-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204082-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204082-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204082-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204082-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204082-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204082-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204082-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204082-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204082-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204082-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204082-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204082-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204082-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204082-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204082-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204082-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204082-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204082-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204082-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204082-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204082-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204082-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204082-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204082-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204082-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204082-002	AB	1	`5aa47cf7b7d7…`

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
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	aca478a7-eff6-4cd5-93a8-2dca69883a4b	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204082 application number: ANDA204082 ndc (product): 71335-1700
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	d585d916-2a5d-4baa-9c64-52b12313aba3	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204082 application number: ANDA204082 ndc (product): 63629-7524
Desvenlafaxine	DESVENLAFAXINE	Hikma Pharmaceuticals USA Inc.	662890ff-d254-40e0-a9fe-f07ab94d65d6	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0054-0603 ndc (product): 0054-0400
Desvenlafaxine	DESVENLAFAXINE	A-S Medication Solutions	7107a864-fcb3-4cbf-9fcb-061bef13be2d	2024-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204082 application number: ANDA204082 ndc (product): 50090-4806
Desvenlafaxine	DESVENLAFAXINE	American Health Packaging	e0dbbdbc-9438-407a-b3e1-f3bb7f177a4e	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204082 application number: ANDA204082 ndc (product): 60687-607

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0400	Desvenlafaxine	Desvenlafaxine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0400	Desvenlafaxine	Desvenlafaxine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0400	Desvenlafaxine	Desvenlafaxine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0400	Desvenlafaxine	Desvenlafaxine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0603	Desvenlafaxine	Desvenlafaxine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0603	Desvenlafaxine	Desvenlafaxine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0603	Desvenlafaxine	Desvenlafaxine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0603	Desvenlafaxine	Desvenlafaxine	West-Ward Pharmaceuticals Corp.	ANDA	Current
50090-4806	Desvenlafaxine	Desvenlafaxine	A-S Medication Solutions	ANDA	Current
50090-4806	Desvenlafaxine	Desvenlafaxine	A-S Medication Solutions	ANDA	Current
60687-607	Desvenlafaxine	Desvenlafaxine	American Health Packaging	ANDA	Current
60687-607	Desvenlafaxine	Desvenlafaxine	American Health Packaging	ANDA	Current
63629-7524	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
63629-7524	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
63629-7524	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
70518-2244	Desvenlafaxine	Desvenlafaxine	REMEDYREPACK INC.	ANDA	Current
71335-1700	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-1700	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32505	ORIG	2016-02-18