Application 200834

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 1.

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
A200834-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A200834-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A200834-003	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
A200834-001	AB
A200834-002	AB
A200834-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200834-003	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	A200834-001	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	A200834-002	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	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200834-003	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	A200834-001	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	A200834-002	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	A200834-003	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	A200834-001	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	A200834-002	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	A200834-003	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	A200834-001	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	A200834-002	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	A200834-003	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	A200834-001	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	A200834-002	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	A200834-003	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	A200834-001	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	A200834-002	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	A200834-003	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	A200834-001	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	A200834-002	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	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200834-003	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	A200834-001	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	A200834-002	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	A200834-003	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	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200834-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200834-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200834-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200834-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200834-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200834-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200834-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200834-001	AB	1	`8072bd15b7f6…`

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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	4e3053b9-cdec-4f4d-85ae-2e55cf1cc185	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834 ndc (product): 70518-2532
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	50d3b487-9f65-4e2f-b6eb-9533964f8972	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834 ndc (product): 70518-2259
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	ac9b972d-8b8a-4727-90c2-b208f91272fd	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834 ndc (product): 70518-2107
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	5358f20f-b864-0aae-e063-6394a90a7eab	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	5359012e-a868-3aa3-e063-6294a90a74e2	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Asclemed USA, Inc.	c69d16fd-b82d-4708-aece-ab4f60b29cc6	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	7852be9e-0c1d-47a8-9513-c3a04b365763	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	28c8f404-1dbd-4140-8959-32624d7c7724	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Cardinal Health 107, LLC	7588ffdc-034d-4baf-9889-9a0ded265be5	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	33068acd-d361-4cd9-b994-02a7865ff04f	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	812ca864-8230-4c84-a7f4-d1b926dee31a	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	569e10d1-6432-473c-a026-ac438bd77bcd	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine HCL ER	VENLAFAXINE HCL ER	Direct_Rx	f32ca617-66e0-41d8-e053-2a95a90ae40a	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	QPharma, Inc.	4992698e-5d5a-6468-e063-6394a90ab404	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e2d5a2d5-5e55-426c-bc8d-d29729eba775	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Northwind Health Company, LLC	f757cac4-efa7-668c-e053-6294a90a720d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Major Pharmaceuticals	d962f5af-7642-4c6e-b7be-3e089fe48873	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	22980b32-cbae-4f37-9fc0-b47221b2c32e	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834 ndc (product): 68788-8140
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0c404290-2806-4756-bca3-2d639b400963	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834 ndc (product): 68788-7919

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 125 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68084-713	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	American Health Packaging	ANDA	Current
68084-713	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	American Health Packaging	ANDA	Current
68084-713	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	American Health Packaging	ANDA	Current
68788-7919	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7919	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8140	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0982	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0982	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0982	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2107	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2107	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2107	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2107	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2121	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2121	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2121	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2121	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2121	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2121	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2259	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2259	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2259	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2259	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2259	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2532	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2532	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2532	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2532	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-464	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-494	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-369	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-369	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-408	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-408	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-1642	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1642	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1864	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1864	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1993	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-066	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
72189-363	Venlafaxine HCL ER	Venlafaxine HCL ER	Direct_Rx	ANDA	Current
72189-363	Venlafaxine HCL ER	Venlafaxine HCL ER	Direct_Rx	ANDA	Current
82009-056	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	QUALLENT PHARMACEUTICALS HEALTH LLC	ANDA	Current
82009-057	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	QUALLENT PHARMACEUTICALS HEALTH LLC	ANDA	Current
82009-058	Venlafaxine Hydrochloride	Venlafaxine Hydrochloride	QUALLENT PHARMACEUTICALS HEALTH LLC	ANDA	Current