Application 208399

Type: NDA
Sponsor: TERSERA THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VARUBI	ROLAPITANT HYDROCHLORIDE	EMULSION;INTRAVENOUS	EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)	Yes	No

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
N208399-001	VARUBI	ROLAPITANT HYDROCHLORIDE	EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)	EMULSION / INTRAVENOUS		RLD	2017-10-25

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208399-001	7981905	2027-04-04	U-1741		2017-11-22
N208399-001	8178550	2027-04-04		Drug substance, Drug product	2017-11-22
N208399-001	8404702	2027-04-04	U-1741		2017-11-22
N208399-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2017-11-16
N208399-001	8470842	2029-01-18	U-1741		2017-11-22
N208399-001	9101615	2032-07-14	U-1741		2017-11-22

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	N208399-001	VARUBI	EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)	EMULSION / INTRAVENOUS	RLD	2017-10-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208399-001	VARUBI	EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)	EMULSION / INTRAVENOUS	RLD	2017-10-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208399-001	VARUBI	EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)	EMULSION / INTRAVENOUS	RLD	2017-10-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208399-001	VARUBI	EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)	EMULSION / INTRAVENOUS	RLD	2017-10-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 282 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208399-001	7981905	2027-04-04	U-1741		2017-11-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208399-001	8178550	2027-04-04		Drug substance, Drug product	2017-11-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208399-001	8404702	2027-04-04	U-1741		2017-11-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208399-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2017-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208399-001	8470842	2029-01-18	U-1741		2017-11-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208399-001	9101615	2032-07-14	U-1741		2017-11-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208399-001	7981905	2027-04-04	U-1741		2017-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208399-001	8178550	2027-04-04		Drug substance, Drug product	2017-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208399-001	8404702	2027-04-04	U-1741		2017-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208399-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2017-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208399-001	8470842	2029-01-18	U-1741		2017-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208399-001	9101615	2032-07-14	U-1741		2017-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208399-001	7981905	2027-04-04	U-1741		2017-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208399-001	8178550	2027-04-04		Drug substance, Drug product	2017-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208399-001	8404702	2027-04-04	U-1741		2017-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208399-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208399-001	8470842	2029-01-18	U-1741		2017-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208399-001	9101615	2032-07-14	U-1741		2017-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208399-001	7981905	2027-04-04	U-1741		2017-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208399-001	8178550	2027-04-04		Drug substance, Drug product	2017-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208399-001	8404702	2027-04-04	U-1741		2017-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208399-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208399-001	8470842	2029-01-18	U-1741		2017-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208399-001	9101615	2032-07-14	U-1741		2017-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208399-001	7981905	2027-04-04	U-1741		2017-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208399-001	8178550	2027-04-04		Drug substance, Drug product	2017-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208399-001	8404702	2027-04-04	U-1741		2017-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208399-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208399-001	8470842	2029-01-18	U-1741		2017-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208399-001	9101615	2032-07-14	U-1741		2017-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208399-001	7981905	2027-04-04	U-1741		2017-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208399-001	8178550	2027-04-04		Drug substance, Drug product	2017-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208399-001	8404702	2027-04-04	U-1741		2017-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208399-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208399-001	8470842	2029-01-18	U-1741		2017-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208399-001	9101615	2032-07-14	U-1741		2017-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208399-001	7981905	2027-04-04	U-1741		2017-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208399-001	8178550	2027-04-04		Drug substance, Drug product	2017-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208399-001	8404702	2027-04-04	U-1741		2017-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208399-001	7049320	2028-08-19	U-1741	Drug substance, Drug product	2017-11-16	`fd3edfee7708…`

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	N208399-001	NCE	2020-09-01	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208399-001	NCE	2020-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208399-001	NCE	2020-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208399-001	NCE	2020-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208399-001	NCE	2020-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208399-001	NCE	2020-09-01	`ea99ee380514…`

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
Varubi	ROLAPITANT	Luria Therapeutics LLC	8670c3cf-82d9-466d-be49-de33d8c8742b	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Varubi
Varubi	ROLAPITANT	TerSera Therapeutics LLC	a52896cd-4a98-49b8-82db-bf1985a64d97	2020-08-19	Warnings, Adverse reactions	Name fallback brand name: Varubi

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69656-102	Varubi	rolapitant	Tesaro, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64363	SUPPL	2020-08-21
64325	SUPPL	2020-08-20
56728	ORIG	2018-12-13
53699	SUPPL	2018-04-16
53685	SUPPL	2018-04-16
50229	ORIG	2017-10-30
50195	ORIG	2017-10-26