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 43.

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 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078517-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078517-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078517-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078517-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078517-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
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…`

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 2 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	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	Macleods Pharmaceuticals Limited	3e51f786-3691-4ec4-836b-7f2c9a385aa7	2026-05-15	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
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	1775b8bf-cd4f-4a8a-abd1-78d90de54fdd	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	67059969-e291-4609-b130-0faacf2a19f0	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2a7d760c-fd9f-8026-e063-6294a90aaa43	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	7852be9e-0c1d-47a8-9513-c3a04b365763	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	28c8f404-1dbd-4140-8959-32624d7c7724	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Cardinal Health 107, LLC	7588ffdc-034d-4baf-9889-9a0ded265be5	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	33068acd-d361-4cd9-b994-02a7865ff04f	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	812ca864-8230-4c84-a7f4-d1b926dee31a	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	569e10d1-6432-473c-a026-ac438bd77bcd	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	c0fa9a3b-692e-2c2e-e053-2995a90aa83a	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Epic Pharma, LLC	430777f0-347c-4f21-8c5d-55f4e9897e74	2026-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	ddb51556-0292-4aa9-b781-a402c912591f	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	d7d1319c-500e-4ca0-83a1-a739cfa01cf7	2026-02-09	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.