Application 211323

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, EXTENDED RELEASE;ORAL	EQ 75MG BASE	No	No
002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	No	No
003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 225MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211323-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29
A211323-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29
A211323-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211323-001	AB
A211323-002	AB
A211323-003	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
2026-08-18 06:07:40	2026-07	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`1e350fbaab3a…`

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
2026-08-18 06:07:40	2026-07	A211323-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211323-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211323-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211323-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211323-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211323-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211323-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211323-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211323-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211323-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211323-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211323-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211323-001	AB	1	`1e350fbaab3a…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine	VENLAFAXINE	Modavar Pharmaceuticals LLC	14b38374-7287-47dd-8ef9-e88bd5b23a26	2024-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211323 application number: ANDA211323
Venlafaxine	VENLAFAXINE	Cadila Pharmaceuticals Limited	516e7566-35c2-4a25-88d8-54d9dbc8f6be	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211323 application number: ANDA211323 ndc (product): 71209-089 ndc (product): 71209-088 ndc (product): 71209-087
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e1	2021-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211323 application number: ANDA211323 ndc (product): 75834-217 ndc (product): 75834-219 ndc (product): 75834-218

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-3136	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3136	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
71209-087	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-087	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-087	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-088	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-088	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-088	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-089	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-089	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
71209-089	Venlafaxine	Venlafaxine	Cadila Pharmaceuticals Limited	ANDA	Current
75834-217	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-217	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-218	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-218	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-219	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-219	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current