Application 091136

Type: ANDA
Sponsor: MYLAN ASI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	No	No
002	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091136-001	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP		2010-04-09
A091136-002	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP		2010-04-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091136-001	AP
A091136-002	AP

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091136-001	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091136-002	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-04-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091136-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091136-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091136-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091136-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091136-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091136-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091136-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091136-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091136-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091136-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091136-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091136-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091136-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091136-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091136-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091136-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091136-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091136-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091136-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091136-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091136-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091136-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091136-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091136-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091136-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091136-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091136-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091136-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091136-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091136-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091136-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091136-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091136-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091136-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091136-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091136-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091136-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091136-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091136-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091136-002	AP	1	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Granisetron Hydrochloride	GRANISETRON HYDROCHLORIDE	Mylan Institutional LLC	8d88adba-7f5e-4e97-84b3-6ca8ec98c023	2017-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091136 application number: ANDA091136 ndc (product): 67457-863 ndc (product): 67457-861

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-779	granisetron hydrochloride	granisetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
67457-861	Granisetron Hydrochloride	Granisetron Hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-861	Granisetron Hydrochloride	Granisetron Hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-863	Granisetron Hydrochloride	Granisetron Hydrochloride	Mylan Institutional LLC	ANDA	Current
67457-863	Granisetron Hydrochloride	Granisetron Hydrochloride	Mylan Institutional LLC	ANDA	Current