Application 020305

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KYTRIL	GRANISETRON HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	Yes	No
002	KYTRIL	GRANISETRON HYDROCHLORIDE	TABLET;ORAL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	Yes	No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
N020305-001	KYTRIL	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-16
N020305-002	KYTRIL	GRANISETRON HYDROCHLORIDE	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-06-15

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2019-12-13 00:20 UTC	2019-12	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1995-03-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons	TABLET / ORAL	RLD	1998-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020305-001	KYTRIL	EQ 1MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-03-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020305-002	KYTRIL	EQ 2MG BASE Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-06-15	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Eugia US LLC	783e9d68-2371-4fd4-8d7a-a5e36f8718d0	2025-04-24	Warnings, Adverse reactions	Name fallback generic name: GRANISETRON HYDROCHLORIDE
Granisol	GRANISETRON HYDROCHLORIDE	Intra-Sana Laboratories	2758eb4d-2fe0-4f74-b3f5-b4903009e97c	2025-03-21	Warnings, Adverse reactions	Name fallback generic name: GRANISETRON HYDROCHLORIDE
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	df4b6775-4337-41e0-815a-b064d98c3fe1	2024-02-29	Warnings, Adverse reactions	Name fallback generic name: GRANISETRON HYDROCHLORIDE
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e07862df-f324-4575-a1ef-f7e1cbab4c7a	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: GRANISETRON HYDROCHLORIDE
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Bionpharma Inc.	50b713d3-7ca8-465a-aefa-65ddbe17b934	2023-12-16	Warnings, Adverse reactions	Name fallback generic name: GRANISETRON HYDROCHLORIDE
Granisetron	GRANISETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	dddc8714-383f-4bc5-a468-ae89dbc802b4	2022-11-15	Warnings, Adverse reactions	Name fallback generic name: GRANISETRON HYDROCHLORIDE
Granisetron hydrochloride	GRANISETRON HYDROCHLORIDE	Natco Pharma Limited	d2be8de3-04fe-4e92-82b4-98d749b89596	2019-10-25	Warnings, Adverse reactions	Name fallback generic name: GRANISETRON HYDROCHLORIDE
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Mylan Institutional LLC	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	2017-08-31	Warnings, Adverse reactions	Name fallback generic name: GRANISETRON HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
2321	SUPPL	2009-11-12
12433	SUPPL	2009-10-14
20592	SUPPL	2009-09-16
34494	SUPPL	2005-11-30
2320	SUPPL	2005-11-30
41276	SUPPL	1999-07-27
24757	SUPPL	1999-07-27
41275	SUPPL	1997-10-06