Application 217841

Type: ANDA
Sponsor: ABON PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	No	No
002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 225MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A217841-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2025-02-07
A217841-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2025-02-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217841-001	AB
A217841-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217841-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217841-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217841-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217841-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217841-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217841-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217841-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217841-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217841-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217841-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217841-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217841-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-02-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217841-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217841-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217841-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217841-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217841-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217841-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217841-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217841-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217841-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217841-002	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217841-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217841-002	AB	1	`a50c72e98297…`

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 7 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	52319578-f7cc-4b87-b532-f341854e40b4	2023-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Proficient Rx LP	922388b3-fc1c-46c6-b314-9049bd042df7	2023-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Lifesciences Limited	1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b	2023-05-19		Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	0aedeaf8-9b6c-4a44-a5fe-9d74516f542d	2023-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	f02cc6e8-186f-46e8-9675-70fd55d002c4	2023-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: venlafaxine hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	5bd03cf1-e8fc-44f3-9c41-06515b897f3b	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	8d6e699b-24bf-4e77-8a7f-acd496a700c7	2023-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: venlafaxine hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	106d0d7b-925b-74e7-83cb-562144ce1f92	2022-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	2022-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: venlafaxine hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Proficient Rx LP	aaa14e95-904e-45c6-be4d-c94167b20300	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Proficient Rx LP	18e77a42-6552-4042-9ed3-046c94f4f921	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE	XLCare Pharmaceuticals, Inc.	68f40801-d35e-464e-ac94-21016b617ea2	2021-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE	Camber Pharmaceuticals, Inc.	8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd3	2021-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e1	2021-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VENLAFAXINE HYDROCHLORIDE generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Annora Pharma Private Limited	e901e476-58bd-4204-baaa-a4634ae65ab3	2020-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VENLAFAXINE HYDROCHLORIDE generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Dr.Reddy's Laboratories Ltd.	7027be98-61d6-a986-c9df-60ceef5f7ff0	2018-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: venlafaxine hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE