Application 206250

Type: ANDA
Sponsor: CADILA PHARMS 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 42.

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
A206250-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21
A206250-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21
A206250-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21
A206250-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21
A206250-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206250-001	AB
A206250-002	AB
A206250-003	AB
A206250-004	AB
A206250-005	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 · 210 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
2026-08-18 06:07:40	2026-07	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206250-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206250-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206250-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-005	AB	1	`2680178bc6a6…`

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	VENLAFAXINE	Cadila Pharmaceuticals Limited	2ed61dcf-42e3-47cf-a607-459eef5fea98	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206250 application number: ANDA206250 ndc (product): 71209-028 ndc (product): 71209-029 ndc (product): 71209-026 ndc (product): 71209-027 ndc (product): 71209-025

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71209-025	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-025	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-025	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-025	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-026	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-026	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-026	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-026	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-027	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-027	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-027	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-027	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-028	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-028	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-028	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-028	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-029	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-029	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-029	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-029	VENLAFAXINE	venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current