Application 078301

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	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	TE codes	Approval date
A078301-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13
A078301-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13
A078301-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13
A078301-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13
A078301-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078301-001	AB
A078301-002	AB
A078301-003	AB
A078301-004	AB
A078301-005	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 6 · 215 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
2026-09-14 22:38:34	2026-08	A078301-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078301-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078301-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078301-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078301-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078301-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078301-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078301-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078301-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078301-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078301-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078301-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078301-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078301-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078301-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078301-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078301-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078301-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078301-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078301-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078301-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078301-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078301-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078301-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078301-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078301-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078301-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078301-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078301-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078301-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078301-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078301-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078301-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078301-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078301-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078301-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078301-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078301-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078301-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078301-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078301-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078301-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078301-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078301-005	AB	1	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	106d0d7b-925b-74e7-83cb-562144ce1f92	2022-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078301 application number: ANDA078301 ndc (product): 55111-546 ndc (product): 55111-547 ndc (product): 55111-548 ndc (product): 55111-545 ndc (product): 55111-549

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-545	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-545	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-545	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-546	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-546	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-546	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-547	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-547	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-547	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-548	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-548	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-548	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-549	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-549	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-549	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current