Application 078127

Type: ANDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	SOLUTION;ORAL	EQ 4MG BASE/5ML	No	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
A078127-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2007-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078127-001	AA

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	Product TE source text	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A078127-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-06-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078127-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-06-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078127-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-06-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078127-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2007-06-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078127-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078127-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078127-001	AA	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078127-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078127-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078127-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078127-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078127-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078127-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078127-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078127-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078127-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078127-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078127-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078127-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078127-001	AA	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A078127-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078127-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078127-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078127-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078127-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078127-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078127-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078127-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078127-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078127-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078127-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078127-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078127-001	AA	1	`a50c72e98297…`

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
Ondansetron	ONDANSETRON	PAI Holdings, LLC dba PAI Pharma	68a4d845-0c1c-4867-bfca-c0fb11dc93cd	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078127 application number: ANDA078127

Reported adverse events (FAERS/openFDA)#

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