Application 205468

Type: ANDA
Sponsor: NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205468-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-24
A205468-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205468-002	AB
A205468-003	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 3 · 86 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	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A205468-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205468-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205468-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205468-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205468-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205468-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205468-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205468-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205468-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205468-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205468-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205468-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205468-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205468-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205468-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205468-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205468-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205468-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205468-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205468-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205468-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205468-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205468-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205468-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205468-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205468-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205468-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205468-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205468-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205468-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205468-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205468-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205468-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205468-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205468-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205468-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205468-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205468-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205468-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A205468-003	AB	1	`f41ea6bd6efb…`

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	Westminster Pharmaceuticals, LLC	349308ef-2caf-4fec-b428-56ae06c6771d	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205468 application number: ANDA205468

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29033-045	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Nostrum Laboratories, Inc.	ANDA	Current
29033-045	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Nostrum Laboratories, Inc.	ANDA	Current
29033-045	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Nostrum Laboratories, Inc.	ANDA	Current
29033-046	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Nostrum Laboratories, Inc.	ANDA	Current
29033-046	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Nostrum Laboratories, Inc.	ANDA	Current
29033-046	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Nostrum Laboratories, Inc.	ANDA	Current
60429-866	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-866	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-866	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Golden State Medical Supply	ANDA	Current
60429-867	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-867	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-867	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Golden State Medical Supply	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47758	ORIG	2017-03-29