Application 078865

Type: ANDA
Sponsor: WOCKHARDT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 37.5MG BASE	No	No
002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 75MG BASE	No	No
003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 150MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078865-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A078865-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A078865-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078865-001	AB
A078865-002	AB
A078865-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078865-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078865-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078865-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078865-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078865-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078865-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078865-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078865-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078865-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078865-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078865-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078865-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078865-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078865-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078865-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078865-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078865-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078865-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078865-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078865-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078865-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078865-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078865-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078865-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078865-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078865-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078865-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078865-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078865-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078865-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078865-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078865-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078865-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078865-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078865-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078865-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078865-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078865-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078865-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078865-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078865-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078865-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078865-001	AB	1	`301d65b070ca…`

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 3 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	Coupler LLC	4a007068-89d9-c296-e063-6394a90ad6d0	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	85740bf6-7e88-4a6e-9ec9-3455e3b95e59	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	ea5914ab-28f3-4cb3-bade-6eaccac214e4	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	bce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	QPharma, Inc.	4992698e-5d5a-6468-e063-6394a90ab404	2026-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	b19ec628-4034-4316-ad3d-46c1ee220728	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	806b3e38-3b2a-4aaa-973c-e2d921bb353e	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	c4312b7b-7a42-45f1-b6e6-e20ea76020c4	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e2d5a2d5-5e55-426c-bc8d-d29729eba775	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	AvKARE	7f224c88-9425-9ef0-01bc-dcf3bdafbd89	2026-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	9fda0f8d-b24e-4581-9dca-7aaaf86e2413	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b5c729-17c8-7ecc-e053-2a95a90a2e53	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Northwind Health Company, LLC	fb076577-b9da-c78b-e053-6394a90a107b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Northwind Health Company, LLC	f757cac4-efa7-668c-e053-6294a90a720d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Chartwell RX, LLC	85ec2d3f-49e4-4ac5-bd4a-c227589dbf58	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: venlafaxine hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	QPharma, Inc.	9e745ad7-be4f-4369-be23-587e1154e4ab	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	0a1b6bcd-8d46-44ab-bc5d-65515601d2ff	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	349308ef-2caf-4fec-b428-56ae06c6771d	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Major Pharmaceuticals	d962f5af-7642-4c6e-b7be-3e089fe48873	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	22980b32-cbae-4f37-9fc0-b47221b2c32e	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6246	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
55648-716	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt Limited	ANDA	Current
55648-717	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt Limited	ANDA	Current
55648-718	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt Limited	ANDA	Current
63739-633	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	McKesson Corporation	ANDA	Current
63739-633	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-633	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	McKesson Corporation dba SKY Packaging	ANDA	Current
64679-716	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-716	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-716	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-717	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-717	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-717	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-718	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-718	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current
64679-718	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Wockhardt USA LLC.	ANDA	Current