Application 204095

Type: ANDA
Sponsor: MYLAN

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

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
A204095-001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL			2015-06-29
A204095-002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL			2015-06-29

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	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204095-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204095-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL		2015-06-29	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204095-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204095-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204095-001	AB	1	`b00525d2431f…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Breckenridge Pharmaceutical, Inc	25bdfc41-c7cb-4d16-b6a8-f102f9b8c984	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	56c9e8ee-1460-4a4c-8033-65d9afb358c8	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine Succinate generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	593d340b-f49a-455b-aeb2-5a1eaf7b6cbe	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine Succinate generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	A-S Medication Solutions	5755f1b2-c10b-47f6-a08d-38d1c05bd353	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine Succinate generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	5f349cc5-b803-462d-b323-d681bd1a02f0	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine Succinate generic name: DESVENLAFAXINE SUCCINATE
Pristiq Extended-Release	DESVENLAFAXINE SUCCINATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0f43610c-f290-46ea-d186-4f998ed99fce	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Preferred Pharmaceuticals Inc.	b4a5efab-3765-4ea5-a8cd-66e67e76c845	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Preferred Pharmaceuticals Inc.	453a5759-2f0d-421d-be78-81ab97c8ce77	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine Succinate generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Preferred Pharmaceutical, Inc.	4b786ea1-309d-440c-b091-38d6b1f7fbd3	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Lupin Pharmaceuticals, Inc.	e96272a2-8f73-4fbe-a8d4-a78d4ad68831	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine Succinate generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Coupler LLC	325be002-4db2-40e9-e063-6394a90ae94e	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
desvenlafaxine	DESVENLAFAXINE SUCCINATE	DIRECT RX	b3ef2bb2-c336-2d57-e053-2995a90a5fe0	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	A-S Medication Solutions	7ee04e8c-ce6c-450d-9122-2bffd170bfd7	2024-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine Succinate generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Bryant Ranch Prepack	5e78c812-7fe6-4a4e-8465-0415df2e9851	2024-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine Succinate	DESVENLAFAXINE SUCCINATE	Macleods Pharmaceuticals Limited	edf18b33-a226-44f8-9f42-c409e691ee64	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desvenlafaxine Succinate generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	A-S Medication Solutions	88ac1206-864b-47a3-82ab-be83bc9532f3	2023-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	A-S Medication Solutions	b2a3edb8-ba64-4ead-b452-d6c8dbaba91d	2023-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Proficient Rx LP	d4542c5e-f9e8-49c7-afa6-9dd4c4d485f2	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine	DESVENLAFAXINE SUCCINATE	Alembic Pharmaceuticals Limited	5bd203d2-477e-4d12-a875-cb8009f42410	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE SUCCINATE

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4230	Desvenlafaxine	desvenlafaxine	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4230	Desvenlafaxine	desvenlafaxine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4231	Desvenlafaxine	desvenlafaxine	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4231	Desvenlafaxine	desvenlafaxine	Mylan Pharmaceuticals Inc.	ANDA	Current
68151-5295	Desvenlafaxine	desvenlafaxine	Carilion Materials Management	ANDA	Current
71335-0798	Desvenlafaxine	desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-0798	Desvenlafaxine	desvenlafaxine	Bryant Ranch Prepack	ANDA	Current