Application 204684

Type: NDA
Sponsor: KNIGHT THERAPS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMPAVIDO	MILTEFOSINE	CAPSULE;ORAL	50MG	Yes	Yes

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

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
N204684-001	IMPAVIDO	MILTEFOSINE	50MG	CAPSULE / ORAL		RLD, RS	2014-03-19

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204684-001	NCE	2019-03-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204684-001	ODE-63	2021-03-19	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N204684-001	ODE-63	2021-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204684-001	ODE-63	2021-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204684-001	ODE-63	2021-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204684-001	ODE-63	2021-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204684-001	ODE-63	2021-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204684-001	NCE	2019-03-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204684-001	ODE-63	2021-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204684-001	NCE	2019-03-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204684-001	ODE-63	2021-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204684-001	NCE	2019-03-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204684-001	ODE-63	2021-03-19	`ea99ee380514…`

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69051-300	IMPAVIDO	miltefosine	Profounda, Inc.	NDA	Current
69051-300	IMPAVIDO	miltefosine	Profounda, Inc.	NDA	Current
69051-300	IMPAVIDO	miltefosine	Profounda, Inc.	NDA	Current
69051-300	IMPAVIDO	miltefosine	Profounda, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81625	SUPPL	2025-03-18
81624	SUPPL	2025-03-18
81623	SUPPL	2025-03-18
81616	SUPPL	2025-03-17
81615	SUPPL	2025-03-17
81614	SUPPL	2025-03-17
67655	SUPPL	2021-06-02
67596	SUPPL	2021-05-26
22963	ORIG	2014-04-18
10380	ORIG	2014-03-21
40414	ORIG	2014-03-20