Application 215429

Type: NDA
Sponsor: ALMATICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENBYSI XR	VENLAFAXINE BESYLATE	TABLET, EXTENDED RELEASE; ORAL	112.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215429-001	VENLAFAXINE BESYLATE	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2022-06-29

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215429-001	7776358	2028-05-16		Drug product	2022-07-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215429-001	VENLAFAXINE BESYLATE	EQ 112.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-06-29	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215429-001	6717015	2023-03-27	U-451	Drug substance, Drug product	2022-07-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215429-001	7776358	2028-05-16		Drug product	2022-07-20	`a50c72e98297…`

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	Almatica Pharma LLC	e81a2daf-b8b2-7c05-b532-bc775700b100	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215429 application number: NDA215429 ndc (product): 52427-632

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52427-632	venlafaxine	venlafaxine	Almatica Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75237	SUPPL	2023-08-22
75202	SUPPL	2023-08-22
75201	SUPPL	2023-08-22
73637	ORIG	2023-03-01
73636	ORIG	2023-03-01
71501	ORIG	2022-06-30
71500	ORIG	2022-06-30
71499	ORIG	2022-06-30
71498	ORIG	2022-06-30
71497	ORIG	2022-06-30
71496	ORIG	2022-06-30