Application 204683

Type: NDA
Sponsor: OSMOTICA PHARM CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KHEDEZLA	DESVENLAFAXINE	TABLET, EXTENDED RELEASE;ORAL	50MG	No	No
002	KHEDEZLA	DESVENLAFAXINE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No

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
N204683-001	KHEDEZLA	DESVENLAFAXINE	50MG	TABLET, EXTENDED RELEASE / ORAL			2013-07-10
N204683-002	KHEDEZLA	DESVENLAFAXINE	100MG	TABLET, EXTENDED RELEASE / ORAL			2013-07-10

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	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204683-001	KHEDEZLA	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204683-002	KHEDEZLA	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-07-10	`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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DESVENLAFAXINE	DESVENLAFAXINE	Advagen Pharma Ltd	ff837eb1-24c3-4c63-9b4b-c6b5935a9b47	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	1d8889c9-9403-4b4b-8abd-7dc9a9fc1816	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	a6c2316d-2a51-4975-a061-dc72f2724b2f	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	aca478a7-eff6-4cd5-93a8-2dca69883a4b	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	6741bdef-dc58-47be-b28d-c43476dc8bde	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	Bryant Ranch Prepack	65f4a870-aa91-4d05-a32d-a161295bcc17	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	Bryant Ranch Prepack	643bfe62-7885-4db4-9fff-5d8552b53d14	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Bryant Ranch Prepack	d585d916-2a5d-4baa-9c64-52b12313aba3	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Slate Run Pharmaceuticals, LLC	44f4b928-d5b8-44e7-bfa6-81fb0dc1a718	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	A-S Medication Solutions	fd08efc0-6109-46ee-9556-f77b3f7b6baf	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	Preferred Pharmaceuticals Inc.	5a136b61-f734-43d5-86fc-059ff3b5342a	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Hikma Pharmaceuticals USA Inc.	662890ff-d254-40e0-a9fe-f07ab94d65d6	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	A-S Medication Solutions	48d3a09e-850d-472d-8fb2-996a5167b16d	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	A-S Medication Solutions	b14695b4-c35e-4902-8144-d31d698b1c58	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	Marlex Pharmaceuticals, Inc.	387cea91-6924-2a68-e063-6394a90a8f75	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	NorthStar Rx LLC	3fcc0555-f9cf-4735-a0ef-830c50c390b8	2025-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	NuCare Pharmaceuticals,Inc.	2dce1542-ead5-1b24-e063-6294a90a6df0	2025-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
DESVENLAFAXINE	DESVENLAFAXINE	Bryant Ranch Prepack	5b6e86bc-24a3-4f8c-aff7-6e1e17a7d1a4	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	A-S Medication Solutions	7107a864-fcb3-4cbf-9fcb-061bef13be2d	2024-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE
Desvenlafaxine	DESVENLAFAXINE	American Health Packaging	e0dbbdbc-9438-407a-b3e1-f3bb7f177a4e	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESVENLAFAXINE

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44183-880	Desvenlafaxine	desvenlafaxine	Macoven Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
44183-880	Desvenlafaxine	desvenlafaxine	Macoven Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
44183-890	Desvenlafaxine	desvenlafaxine	Macoven Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
44183-890	Desvenlafaxine	desvenlafaxine	Macoven Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
65224-880	KHEDEZLA	desvenlafaxine	Pernix Therapeutics	NDA	Current
65224-880	KHEDEZLA	desvenlafaxine	Pernix Therapeutics	NDA	Current
65224-890	KHEDEZLA	desvenlafaxine	Pernix Therapeutics	NDA	Current
65224-890	KHEDEZLA	desvenlafaxine	Pernix Therapeutics	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68825	SUPPL	2021-09-30
68824	SUPPL	2021-09-30
68736	SUPPL	2021-09-23
57539	SUPPL	2019-02-13
57386	SUPPL	2019-01-30
57385	SUPPL	2019-01-30
50897	SUPPL	2017-12-27
50805	SUPPL	2017-12-21
50804	SUPPL	2017-12-21
46773	SUPPL	2017-01-10
46715	SUPPL	2017-01-06
45276	SUPPL	2016-09-07
45245	SUPPL	2016-09-06
40413	SUPPL	2014-07-17
32583	SUPPL	2014-07-17
44906	ORIG	2014-03-06
22962	ORIG	2014-03-06
32582	SUPPL	2013-10-01
40412	SUPPL	2013-09-30
32581	ORIG	2013-07-12
19587	ORIG	2013-07-11