Application 077545

Type: ANDA
Sponsor: HIKMA INTL PHARMS

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 43.

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	Approval date
A077545-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06
A077545-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06
A077545-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077545-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077545-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077545-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-09-06	`301d65b070ca…`

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 5 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	476e704c-95ae-4591-94f7-ee4ab827ff13	2021-05-25	Warnings, Adverse reactions	Name fallback brand name: ondansetron hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	bde7c22c-0047-4735-8df6-b48e8dfa478a	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	08db5ce7-4dcf-4581-a0bf-f405cc22b48d	2018-08-27	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-2422	Ondansetron	Ondansetron hydrochloride	West-ward Pharmaceutical Corp	ANDA	Current
0143-2423	Ondansetron	Ondansetron hydrochloride	West-ward Pharmaceutical Corp	ANDA	Current
0143-2424	Ondansetron	Ondansetron	West-ward Pharmaceutical Corp	ANDA	Current