Application 077515

Type: ANDA
Sponsor: FOSUN PHARMA

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
A077515-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13
A077515-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13
A077515-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13
A077515-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13
A077515-005	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	A077515-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077515-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077515-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077515-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077515-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077515-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077515-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077515-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077515-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077515-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077515-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077515-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077515-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077515-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077515-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077515-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077515-002	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	A077515-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077515-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077515-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077515-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077515-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077515-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077515-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077515-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077515-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077515-002	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	A077515-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077515-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077515-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077515-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077515-002	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	A077515-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077515-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077515-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077515-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077515-002	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	A077515-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077515-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077515-005	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 4 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	Preferred Pharmaceuticals, Inc.	b18d726e-cdb2-4c80-a49d-330cddee17e9	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f059	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b055df74-51f9-401f-8cca-24269a0163df	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0c404290-2806-4756-bca3-2d639b400963	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	de6e30f8-c8ef-4016-b228-0f188645347b	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: venlafaxine hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	92b3f73d-d6ca-4d7d-9035-5700f527cb85	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	653f3f95-98d0-4ce0-bf10-ac7938be690e	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3cbe3e18-9a7e-aaa3-e063-6394a90abf92	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	3c2e188f-76aa-a022-e063-6294a90abfc9	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VENLAFAXINE HYDROCHLORIDE generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Trigen Laboratories, LLC	fdaed1c2-dd0a-4bf3-975a-86fe3e7f0c97	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	5c943206-6df8-4fc5-ab1d-d34b9715182c	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VENLAFAXINE HYDROCHLORIDE generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	American Health Packaging	e05bdeb4-07a9-441e-901b-f2aea550db2b	2025-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	35d3148b-52f3-197c-e063-6294a90a44e3	2025-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE	Rising Pharma Holdings, Inc.	074f4478-e81b-45a2-ae85-ffd27bed940f	2025-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Dr.Reddys Laboratories Inc	f5c21429-d5d0-9f93-a465-6e5e0e19ebdd	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: venlafaxine hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	15c77ad7-7edc-4c36-ba3f-3ef05dfb12dc	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	AvPAK	2efde38c-250e-d1b9-e063-6394a90a1b74	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE	Preferred Pharmaceuticals Inc.	edefc932-d25d-4ead-b348-b3b6d9232091	2025-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2cf6e6ad-7d00-0db1-e063-6394a90ab1ec	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Venlafaxine Hydrochloride generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2c2bb0e6-5a73-ff57-e063-6294a90a88d3	2025-01-20	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.