Application 214419

Type: ANDA
Sponsor: ASCENT PHARMS INC

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 37.5MG BASE	No	No
002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 75MG BASE	No	No
003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	No	No
004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 225MG 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214419-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21
A214419-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21
A214419-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21
A214419-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214419-001	AB
A214419-002	AB
A214419-003	AB
A214419-004	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 · 148 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	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 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	A214419-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214419-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214419-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214419-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214419-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214419-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-004	AB	1	`d8e5a09893c0…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE	BluePoint Laboratories	5efe1336-c796-4560-8110-a64c80eefb0c	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214419 application number: ANDA214419 ndc (product): 68001-496 ndc (product): 68001-498 ndc (product): 68001-497 ndc (product): 68001-499
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE	XLCare Pharmaceuticals, Inc.	68f40801-d35e-464e-ac94-21016b617ea2	2021-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214419 application number: ANDA214419 ndc (product): 72865-199 ndc (product): 72865-198 ndc (product): 72865-197 ndc (product): 72865-200
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE	Camber Pharmaceuticals, Inc.	8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd3	2021-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214419 application number: ANDA214419 ndc (product): 31722-126 ndc (product): 31722-123 ndc (product): 31722-124 ndc (product): 31722-125

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-123	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-123	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-124	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-124	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-125	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-125	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-126	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-126	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Camber Pharmaceuticals, Inc.	ANDA	Current
43602-392	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-393	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-394	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-395	VENLAFAXINE HYDROCHLORIDE	venlafaxine	Ascent Pharmaceuticals, Inc.	ANDA	Current
68001-496	VENLAFAXINE HYDROCHLORIDE	venlafaxine	BluePoint Laboratories	ANDA	Current
68001-496	VENLAFAXINE HYDROCHLORIDE	venlafaxine	BluePoint Laboratories	ANDA	Current
68001-497	VENLAFAXINE HYDROCHLORIDE	venlafaxine	BluePoint Laboratories	ANDA	Current
68001-497	VENLAFAXINE HYDROCHLORIDE	venlafaxine	BluePoint Laboratories	ANDA	Current
68001-498	VENLAFAXINE HYDROCHLORIDE	venlafaxine	BluePoint Laboratories	ANDA	Current
68001-498	VENLAFAXINE HYDROCHLORIDE	venlafaxine	BluePoint Laboratories	ANDA	Current
68001-499	VENLAFAXINE HYDROCHLORIDE	venlafaxine	BluePoint Laboratories	ANDA	Current
68001-499	VENLAFAXINE HYDROCHLORIDE	venlafaxine	BluePoint Laboratories	ANDA	Current
72865-197	VENLAFAXINE HYDROCHLORIDE	venlafaxine	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-197	VENLAFAXINE HYDROCHLORIDE	venlafaxine	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-198	VENLAFAXINE HYDROCHLORIDE	venlafaxine	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-198	VENLAFAXINE HYDROCHLORIDE	venlafaxine	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-199	VENLAFAXINE HYDROCHLORIDE	venlafaxine	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-199	VENLAFAXINE HYDROCHLORIDE	venlafaxine	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-200	VENLAFAXINE HYDROCHLORIDE	venlafaxine	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-200	VENLAFAXINE HYDROCHLORIDE	venlafaxine	XLCare Pharmaceuticals, Inc.	ANDA	Current