Application 078539

Type: ANDA
Sponsor: AUROBINDO PHARMA

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
A078539-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31
A078539-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31
A078539-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078539-001	AB
A078539-002	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	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-003	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2007-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078539-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-07-31	`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	A078539-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078539-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078539-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078539-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078539-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078539-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078539-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078539-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078539-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078539-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078539-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078539-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078539-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078539-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078539-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078539-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078539-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078539-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078539-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078539-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078539-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078539-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078539-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078539-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078539-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078539-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078539-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078539-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078539-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078539-003	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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	57b0a1e5-5dfa-64a0-e063-6394a90acf36	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	3f2e8efe-7fd4-407c-a77b-bd6dd04608e2	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	ee3e8cbe-4f0b-4361-a1b5-8329d85a2932	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	561dce26-92fa-e00b-e063-6294a90a1ab2	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	0a14eb9a-0385-40e9-a7ec-71435450ac91	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	5566aebb-d84d-6d6a-e063-6294a90a746f	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	58f16a00-3e66-29de-e053-2991aa0a59a0	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	American Health Packaging	9f015e60-1aec-4ae7-b28f-42f6c8f50455	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539 ndc (product): 68084-220
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Coupler LLC	546191d2-d092-6342-e063-6294a90a0cd3	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	00b17a8e-9d38-a8d4-e063-6294a90a153e	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Redpharm Drug	541b9a0d-ae94-db6f-e063-6394a90a9805	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539 ndc (product): 67296-1562
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	c0be25a0-e13d-4242-93dc-0b86e82aadd7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	5cc67d95-6629-4451-9e34-2f7a60482be5	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	b1324076-f83e-4816-9e02-6b2a689010bc	2026-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron HCL	ONDANSETRON HCL	Advanced Rx of Tennessee, LLC	af735f22-6d6c-6e1f-e053-2a95a90a3532	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	e2c0e86c-e7fc-48f9-a894-02da8761001c	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
ONDANSETRON	ONDANSETRON	Direct_Rx	90b73778-2ab5-5460-e053-2a95a90abbc1	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539 ndc (product): 61919-565
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	e0f69f57-aeb9-4890-85aa-e5976208e8be	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Northwind Health Company, LLC	f76d27c5-acd4-482c-e053-6294a90a5284	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Northwind Health Company, LLC	f29f8ae1-4826-d8eb-e053-2a95a90a691a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078539 application number: ANDA078539

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 231 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60760-637	Ondansetron Hydrochloride	Ondansetron Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-637	Ondansetron Hydrochloride	Ondansetron Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-637	Ondansetron Hydrochloride	Ondansetron Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-637	Ondansetron Hydrochloride	Ondansetron Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-637	Ondansetron Hydrochloride	Ondansetron Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	DIRECT RX	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	DIRECT RX	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	DIRECT RX	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-087	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-565	ONDANSETRON	ONDANSETRON	DIRECT RX	ANDA	Current
61919-565	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-565	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-565	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-565	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
61919-565	ONDANSETRON	ONDANSETRON	Direct_Rx	ANDA	Current
63187-636	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Proficient Rx LP	ANDA	Current
63187-636	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Proficient Rx LP	ANDA	Current
63187-636	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Proficient Rx LP	ANDA	Current
63187-636	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Proficient Rx LP	ANDA	Current
63187-709	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Proficient Rx LP	ANDA	Current
63187-709	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Proficient Rx LP	ANDA	Current
63187-709	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Proficient Rx LP	ANDA	Current
63187-709	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Proficient Rx LP	ANDA	Current
63629-7781	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7781	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7781	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7938	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8111	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8111	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Bryant Ranch Prepack	ANDA	Current
65862-187	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-187	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-187	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-187	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-188	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-188	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-188	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-188	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-189	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-189	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-189	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-189	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
66116-604	Ondansetron Hydrochloride	Ondansetron Hydrochloride	MedVantx, Inc.	ANDA	Current
67046-346	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67296-0902	Ondansetron Hydrochloride	Ondansetron Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0902	Ondansetron Hydrochloride	Ondansetron Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0902	Ondansetron Hydrochloride	Ondansetron Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1562	Ondansetron Hydrochloride	Ondansetron Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1562	Ondansetron Hydrochloride	Ondansetron Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1562	Ondansetron Hydrochloride	Ondansetron Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-1816	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1816	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1816	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2053	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2053	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2053	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2147	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2147	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2855	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4206	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4206	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4208	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4208	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4328	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-4328	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-4328	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmceuticals,Inc.	ANDA	Current
68071-4705	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4705	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4966	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NUCARE PHARMACEUTICALS INC	ANDA	Current
68071-4966	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NUCARE PHARMACEUTICALS INC	ANDA	Current
68071-5047	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5047	Ondansetron Hydrochloride	Ondansetron Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-220	Ondansetron Hydrochloride	Ondansetron Hydrochloride	American Health Packaging	ANDA	Current
68084-220	Ondansetron Hydrochloride	Ondansetron Hydrochloride	American Health Packaging	ANDA	Current
68084-220	Ondansetron Hydrochloride	Ondansetron Hydrochloride	American Health Packaging	ANDA	Current
68084-220	Ondansetron Hydrochloride	Ondansetron Hydrochloride	American Health Packaging	ANDA	Current