Application 077535

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 4MG BASE	No	No
002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 8MG BASE	No	No
003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 24MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077535-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25
A077535-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25
A077535-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077535-001	AB
A077535-002	AB

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 4 · 123 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	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077535-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	A077535-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077535-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077535-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077535-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077535-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077535-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077535-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077535-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077535-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077535-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077535-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077535-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077535-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077535-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077535-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077535-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077535-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077535-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077535-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077535-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077535-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077535-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077535-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077535-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077535-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077535-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077535-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077535-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077535-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077535-003	AB	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	15d0a711-ef3b-4d93-8fbc-17a45f96af8a	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077535 application number: ANDA077535 ndc (product): 43063-770
Ondansetron	ONDANSETRON	Glenmark Pharmaceuticals Inc., USA	eee5217a-eba8-463a-812d-bf3c66f0934f	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077535 application number: ANDA077535 ndc (product): 68462-106 ndc (product): 68462-105
Ondansetron	ONDANSETRON	Redpharm Drug	300b1916-a3d8-0220-e063-6394a90a6f55	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077535 application number: ANDA077535

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-770	Ondansetron	Ondansetron	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-770	Ondansetron	Ondansetron	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-770	Ondansetron	Ondansetron	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-770	Ondansetron	Ondansetron	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-770	Ondansetron	Ondansetron	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63629-5073	Ondansetron	Ondansetron	Bryant Ranch Prepack	ANDA	Current
63629-5083	Ondansetron	Ondansetron	Bryant Ranch Prepack	ANDA	Current
63629-5083	Ondansetron	Ondansetron	Bryant Ranch Prepack	ANDA	Current
68462-105	Ondansetron	Ondansetron	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-105	Ondansetron	Ondansetron	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-105	Ondansetron	Ondansetron	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-105	Ondansetron	Ondansetron	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-106	Ondansetron	Ondansetron	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-106	Ondansetron	Ondansetron	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-106	Ondansetron	Ondansetron	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-106	Ondansetron	Ondansetron	Glenmark Pharmaceuticals Inc., USA	ANDA	Current