Application 204083

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 100MG BASE	No	No
002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG BASE	No	No
003	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204083-001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16
A204083-002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16
A204083-003	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204083-001	AB
A204083-002	AB
A204083-003	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 2 of 2 · 56 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
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204083-001	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204083-002	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204083-003	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-02-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A204083-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204083-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204083-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204083-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204083-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204083-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204083-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204083-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204083-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204083-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204083-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204083-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204083-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204083-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204083-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204083-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204083-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204083-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204083-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204083-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204083-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204083-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204083-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204083-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204083-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204083-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204083-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204083-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204083-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204083-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204083-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204083-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204083-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204083-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204083-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204083-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204083-001	AB	1	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desvenlafaxine	DESVENLAFAXINE	Hikma Pharmaceuticals USA Inc.	662890ff-d254-40e0-a9fe-f07ab94d65d6	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204083 application number: ANDA204083 ndc (product): 0054-0401

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0401	Desvenlafaxine	Desvenlafaxine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0401	Desvenlafaxine	Desvenlafaxine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0401	Desvenlafaxine	Desvenlafaxine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0401	Desvenlafaxine	Desvenlafaxine	West-Ward Pharmaceuticals Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32506	ORIG	2016-02-18