Application 204150

Type: NDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESVENLAFAXINE	DESVENLAFAXINE	TABLET, EXTENDED RELEASE;ORAL	50MG	Yes	Yes
002	DESVENLAFAXINE	DESVENLAFAXINE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N204150-001	DESVENLAFAXINE	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2013-03-04
N204150-002	DESVENLAFAXINE	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2013-03-04

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204150-001	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2013-03-04	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204150-002	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-04	`3a93d1ddd44b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desvenlafaxine	DESVENLAFAXINE	Sun Pharmaceutical Industries, Inc.	91cf39c9-4d26-480a-a3a3-a3d8d4c4d222	2023-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204150 application number: NDA204150 ndc (product): 63304-191 ndc (product): 63304-192
Desvenlafaxine	DESVENLAFAXINE	Alembic Pharmaceuticals Limited	9f74708c-6f6a-46cf-8c79-87a25c2bb6f8	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204150 application number: NDA204150 ndc (product): 46708-152 ndc (product): 46708-153

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-152	Desvenlafaxine	Desvenlafaxine	Alembic Pharmaceuticals Limited	NDA	Current
46708-153	Desvenlafaxine	Desvenlafaxine	Alembic Pharmaceuticals Limited	NDA	Current
63304-191	Desvenlafaxine	Desvenlafaxine	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-191	Desvenlafaxine	Desvenlafaxine	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-191	Desvenlafaxine	Desvenlafaxine	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-191	Desvenlafaxine	Desvenlafaxine	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-192	Desvenlafaxine	Desvenlafaxine	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-192	Desvenlafaxine	Desvenlafaxine	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-192	Desvenlafaxine	Desvenlafaxine	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-192	Desvenlafaxine	Desvenlafaxine	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75260	SUPPL	2023-08-22
75154	SUPPL	2023-08-21
75153	SUPPL	2023-08-21
68718	SUPPL	2021-09-22
68709	SUPPL	2021-09-21
68708	SUPPL	2021-09-21
60738	SUPPL	2019-10-30
60737	SUPPL	2019-10-30
60717	SUPPL	2019-10-30
50893	SUPPL	2017-12-27
50810	SUPPL	2017-12-21
50809	SUPPL	2017-12-21
46967	SUPPL	2017-01-24
46737	SUPPL	2017-01-10
46687	SUPPL	2017-01-06
45327	SUPPL	2016-09-15
40361	SUPPL	2015-05-21
32520	SUPPL	2015-05-19
32519	SUPPL	2014-07-09
10301	SUPPL	2014-07-09
40360	SUPPL	2014-07-08
40359	SUPPL	2014-07-08
24459	ORIG	2013-09-26
22945	ORIG	2013-09-26
40358	ORIG	2013-03-08
32518	ORIG	2013-03-05
32517	ORIG	2013-01-11
10300	ORIG	2013-01-07