Application 210014

Type: ANDA
Sponsor: YICHANG HUMANWELL

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 42.

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
A210014-001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01
A210014-002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01
A210014-003	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210014-001	AB
A210014-002	AB
A210014-003	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 4 · 121 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
2026-08-18 06:07:40	2026-07	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210014-002	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210014-003	DESVENLAFAXINE SUCCINATE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210014-001	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-01	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 113 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210014-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210014-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210014-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210014-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210014-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210014-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210014-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210014-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210014-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210014-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210014-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210014-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210014-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210014-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210014-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210014-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210014-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210014-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210014-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210014-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210014-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210014-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210014-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210014-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210014-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210014-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210014-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210014-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210014-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210014-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210014-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210014-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210014-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210014-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210014-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210014-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210014-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210014-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210014-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210014-001	AB	1	`1e350fbaab3a…`

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	1d8889c9-9403-4b4b-8abd-7dc9a9fc1816	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210014 application number: ANDA210014 ndc (product): 71335-1975
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	a6c2316d-2a51-4975-a061-dc72f2724b2f	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210014 application number: ANDA210014 ndc (product): 71335-1753
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	6741bdef-dc58-47be-b28d-c43476dc8bde	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210014 application number: ANDA210014 ndc (product): 71335-1815
Desvenlafaxine	DESVENLAFAXINE	Slate Run Pharmaceuticals, LLC	44f4b928-d5b8-44e7-bfa6-81fb0dc1a718	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210014 application number: ANDA210014 ndc (product): 70436-012 ndc (product): 70436-036 ndc (product): 70436-013
Desvenlafaxine	DESVENLAFAXINE	A-S Medication Solutions	fd08efc0-6109-46ee-9556-f77b3f7b6baf	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210014 application number: ANDA210014

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70436-012	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-012	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-012	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-012	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-012	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-012	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-013	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-013	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-013	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-013	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-013	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-013	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-036	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-036	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-036	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-036	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-036	Desvenlafaxine	Desvenlafaxine	Slate Run Pharmaceuticals, LLC	ANDA	Current
70518-3195	Desvenlafaxine	Desvenlafaxine	REMEDYREPACK INC.	ANDA	Current
71335-1753	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-1753	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-1753	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-1815	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-1815	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-1975	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-1975	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current
71335-1975	Desvenlafaxine	Desvenlafaxine	Bryant Ranch Prepack	ANDA	Current