Application 078421

Type: ANDA
Sponsor: DR REDDYS LABS 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
A078421-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06
A078421-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06
A078421-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078421-001	AB
A078421-002	AB
A078421-003	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	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`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	A078421-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078421-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078421-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078421-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078421-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078421-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078421-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078421-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078421-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078421-001	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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Dr.Reddys Laboratories Inc	f5c21429-d5d0-9f93-a465-6e5e0e19ebdd	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078421 application number: ANDA078421
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Dr.Reddy's Laboratories Ltd.	7027be98-61d6-a986-c9df-60ceef5f7ff0	2018-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078421 application number: ANDA078421 ndc (product): 55111-455 ndc (product): 55111-453 ndc (product): 55111-454

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-453	venlafaxine hydrochloride	venlafaxine hydrochloride	Dr.Reddy's Laboratories Ltd.	ANDA	Current
55111-454	venlafaxine hydrochloride	venlafaxine hydrochloride	Dr.Reddy's Laboratories Ltd.	ANDA	Current
55111-455	venlafaxine hydrochloride	venlafaxine hydrochloride	Dr.Reddy's Laboratories Ltd.	ANDA	Current