Application 078517

Type: ANDA
Sponsor: PLIVA HRVATSKA DOO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET;ORAL	EQ 25MG BASE	No	No
002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET;ORAL	EQ 37.5MG BASE	No	No
003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET;ORAL	EQ 50MG BASE	No	No
004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET;ORAL	EQ 75MG BASE	No	No
005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET;ORAL	EQ 100MG 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078517-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13
A078517-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13
A078517-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13
A078517-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13
A078517-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`5bbf6a4d5a75…`

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 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	3eef522f-9e95-4668-bb12-09fd47ed0daf	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	b1d21366-f686-4e20-a10f-0c25f517db38	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	f56a0f70-bbb1-4e69-b969-965a72f0e2f0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	4e3053b9-cdec-4f4d-85ae-2e55cf1cc185	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	50d3b487-9f65-4e2f-b6eb-9533964f8972	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	ac9b972d-8b8a-4727-90c2-b208f91272fd	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Yaopharma Co., Ltd.	38fd2c97-cd30-2f7d-e054-00144ff8d46c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	4a82cef5-693e-46e9-90c4-bff753cdce37	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	f50029b8-7d05-445a-9d9f-71a1aee6088b	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	5a990dbd-f280-4caf-b950-4703ee98b230	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	d94e5404-f728-4e4b-af99-8a8e4dfae227	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	c37a73fa-ceee-4555-a61b-e1e66ad6e97d	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	7fcd7995-81fb-4368-bd4c-3726b2ae363e	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	53e5c5a2-b8e7-3d75-e063-6294a90a508b	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	5358f20f-b864-0aae-e063-6394a90a7eab	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	5359012e-a868-3aa3-e063-6294a90a74e2	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	NorthStar RxLLC	b865c175-e75d-4cb4-ac29-dec72226302c	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VENLAFAXINE HYDROCHLORIDE generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Asclemed USA, Inc.	c69d16fd-b82d-4708-aece-ab4f60b29cc6	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	7aa3edba-4248-49bb-86f7-06fdbf2a6fb7	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	e2fa1bb0-ab86-4499-84cb-ff5e02a16991	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE

Application 078517

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#