Application 205583

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESVENLAFAXINE	DESVENLAFAXINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	Yes	No
002	DESVENLAFAXINE	DESVENLAFAXINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205583-001	DESVENLAFAXINE	DESVENLAFAXINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-01-28
N205583-002	DESVENLAFAXINE	DESVENLAFAXINE FUMARATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-01-28

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205583-001	DESVENLAFAXINE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205583-002	DESVENLAFAXINE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-01-28	`3a93d1ddd44b…`

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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DESVENLAFAXINE	DESVENLAFAXINE	Advagen Pharma Ltd	ff837eb1-24c3-4c63-9b4b-c6b5935a9b47	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Breckenridge Pharmaceutical, Inc	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	1d8889c9-9403-4b4b-8abd-7dc9a9fc1816	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	a6c2316d-2a51-4975-a061-dc72f2724b2f	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	aca478a7-eff6-4cd5-93a8-2dca69883a4b	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	6741bdef-dc58-47be-b28d-c43476dc8bde	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
DESVENLAFAXINE	DESVENLAFAXINE	Bryant Ranch Prepack	65f4a870-aa91-4d05-a32d-a161295bcc17	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	Bryant Ranch Prepack	643bfe62-7885-4db4-9fff-5d8552b53d14	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	d585d916-2a5d-4baa-9c64-52b12313aba3	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Preferred Pharmaceuticals Inc.	b4a5efab-3765-4ea5-a8cd-66e67e76c845	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Preferred Pharmaceutical, Inc.	4b786ea1-309d-440c-b091-38d6b1f7fbd3	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
Desvenlafaxine	DESVENLAFAXINE	Slate Run Pharmaceuticals, LLC	44f4b928-d5b8-44e7-bfa6-81fb0dc1a718	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
Desvenlafaxine	DESVENLAFAXINE	A-S Medication Solutions	fd08efc0-6109-46ee-9556-f77b3f7b6baf	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
DESVENLAFAXINE	DESVENLAFAXINE	Preferred Pharmaceuticals Inc.	5a136b61-f734-43d5-86fc-059ff3b5342a	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Hikma Pharmaceuticals USA Inc.	662890ff-d254-40e0-a9fe-f07ab94d65d6	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
DESVENLAFAXINE	DESVENLAFAXINE	A-S Medication Solutions	48d3a09e-850d-472d-8fb2-996a5167b16d	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	A-S Medication Solutions	b14695b4-c35e-4902-8144-d31d698b1c58	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Marlex Pharmaceuticals, Inc.	387cea91-6924-2a68-e063-6394a90a8f75	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine
DESVENLAFAXINE	DESVENLAFAXINE	NorthStar Rx LLC	3fcc0555-f9cf-4735-a0ef-830c50c390b8	2025-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Coupler LLC	325be002-4db2-40e9-e063-6394a90ae94e	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75239	SUPPL	2023-08-22
75235	SUPPL	2023-08-22
75223	SUPPL	2023-08-22
61237	SUPPL	2019-12-11
61236	SUPPL	2019-12-11
61231	SUPPL	2019-12-11
50900	SUPPL	2017-12-27
50798	SUPPL	2017-12-21
46771	SUPPL	2017-01-10
46714	SUPPL	2017-01-06
44924	ORIG	2014-10-10
22995	ORIG	2014-10-10
40484	SUPPL	2014-07-23
32692	SUPPL	2014-07-23
32691	SUPPL	2014-07-23
19662	SUPPL	2014-07-23
19661	ORIG	2014-01-31
10470	ORIG	2014-01-29