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 5 of 7 · 136 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	Name fallback brand name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochloride ER	VENLAFAXINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8fd4381-52f2-d9c1-e053-6394a90a08e5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride ER	VENLAFAXINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f7a9741b-2dd3-d8f3-e053-6294a90a4d73	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochloride ER	VENLAFAXINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f89bcae0-e714-599a-e053-6294a90a2c3a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2a85bd43-419c-6ed7-e063-6294a90a84d4	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals Inc.	2787aaa2-5210-f7d5-e063-6294a90a7103	2024-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8906ed5a-f69c-0eac-e053-2995a90ae600	2024-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	20a7d922-7f7c-4de4-b5fd-55c13aab060c	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Proficient Rx LP	9f697c00-f5ec-454a-a66c-503aef5fc609	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Proficient Rx LP	613658d3-7eb5-4822-961f-f4c6f6b2a2c1	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Proficient Rx LP	adeba7dd-bd15-4d8f-b703-24c3a208e740	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	baae24d6-e425-4cfc-9a53-3cd223b6d344	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	1e1119f7-0c2e-4587-a24d-0066f73b2e65	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Lifesciences Limited	51334651-7a7f-4653-bf9d-d5be04fd902d	2024-08-14		Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	0ee91447-2c23-4519-81cc-550b5416dd6b	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	1e04fe02-88c9-dafd-e063-6294a90ac4c9	2024-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1bf78b22-a0e3-5f9f-e063-6394a90a3024	2024-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9d38eac0-9d64-1274-e053-2995a90a189a	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8f9d3d30-e9a6-6c85-e053-2a95a90a5524	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	9c061460-3b80-41e1-a87a-1a25108ff740	2024-06-19	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.