Application 078671

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NABUMETONE	NABUMETONE	TABLET;ORAL	500MG	No	No
002	NABUMETONE	NABUMETONE	TABLET;ORAL	750MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078671-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07
A078671-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078671-001	AB
A078671-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB		2008-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078671-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078671-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078671-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078671-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078671-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078671-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078671-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078671-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078671-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078671-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078671-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078671-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078671-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078671-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078671-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078671-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078671-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078671-002	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Northwind Health Company, LLC	b088f564-43ff-8007-e053-2995a90ab012	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671 ndc (product): 51655-396
Nabumetone	NABUMETONE	American Health Packaging	0653b873-b74b-4ec6-b112-675760703d91	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671 ndc (product): 60687-630
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	8f3c1b1d-2765-4cb5-92df-044b99339c92	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671 ndc (product): 43063-972
Nabumetone	NABUMETONE	Exelan Pharmaceuticals Inc.	16e76e29-9315-40c0-b1d6-8d91961063cf	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Cipla USA Inc.	85954380-a520-46d7-89ac-e4b19d6e00a1	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671 ndc (product): 69097-965 ndc (product): 69097-966
Nabumetone	NABUMETONE	Advanced Rx of Tennessee, LLC	af9969df-ce14-c0bc-e053-2995a90a3f59	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 100 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-5843	Nabumetone	Nabumetone	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-5844	Nabumetone	Nabumetone	Liberty Pharmaceuticals, Inc.	ANDA	Current
0615-7630	Nabumetone	nabumetone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7645	Nabumetone	nabumetone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-003	Nabumetone	Nabumetone	Blenheim Pharmacal, Inc.	ANDA	Current
10544-271	Nabumetone	Nabumetone	Blenheim Pharmacal, Inc.	ANDA	Current
21695-230	Nabumetone	Nabumetone	Rebel Distributors Corp.	ANDA	Current
21695-231	Nabumetone	Nabumetone	Rebel Distributors Corp.	ANDA	Current
33261-078	Nabumetone	Nabumetone	Aidarex Pharmaceuticals LLC	ANDA	Current
33358-251	Nabumetone	Nabumetone	RxChange Co.	ANDA	Current
33358-252	Nabumetone	Nabumetone	RxChange Co.	ANDA	Current
35356-686	Nabumetone	Nabumetone	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
35356-726	Nabumetone	Nabumetone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-726	Nabumetone	Nabumetone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
43063-972	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-972	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-972	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-972	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-972	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-972	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-973	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-973	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-973	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-973	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-973	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-351	Nabumetone	Nabumetone	Medsource Pharmaceuticals	ANDA	Current
45865-351	Nabumetone	Nabumetone	Medsource Pharmaceuticals	ANDA	Current
45865-464	Nabumetone	Nabumetone	Medsource Pharmaceuticals	ANDA	Current
45865-464	Nabumetone	Nabumetone	Medsource Pharmaceuticals	ANDA	Current
50090-1531	Nabumetone	Nabumetone	A-S Medication Solutions	ANDA	Current
50090-1531	Nabumetone	Nabumetone	A-S Medication Solutions	ANDA	Current
50090-1531	Nabumetone	Nabumetone	A-S Medication Solutions	ANDA	Current
50090-3433	Nabumetone	Nabumetone	A-S Medication Solutions	ANDA	Current
50090-3433	Nabumetone	Nabumetone	A-S Medication Solutions	ANDA	Current
50090-5386	Nabumetone	Nabumetone	A-S Medication Solutions	ANDA	Current
50436-6046	Nabumetone	Nabumetone	Unit Dose Services	ANDA	Current
50436-6334	Nabumetone	Nabumetone	Unit Dose Services	ANDA	Current
51655-396	Nabumetone	Nabumetone	Northwind Pharmaceuticals	ANDA	Current
51655-396	Nabumetone	Nabumetone	Northwind Pharmaceuticals	ANDA	Current
52959-650	Nabumetone	Nabumetone	H.J. Harkins Company, Inc.	ANDA	Current
52959-656	Nabumetone	Nabumetone	H.J. Harkins Company, Inc.	ANDA	Current
53217-260	Nabumetone	Nabumetone	Aidarex Pharmaceuticals LLC	ANDA	Current
60687-630	Nabumetone	Nabumetone	American Health Packaging	ANDA	Current
60760-015	Nabumetone	Nabumetone	St.Mary's Medical Park Pharmacy	ANDA	Current
60760-696	Nabumetone	Nabumetone	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-668	NABUMETONE	NABUMETONE	DIRECT RX	ANDA	Current
61919-668	NABUMETONE	NABUMETONE	Direct_Rx	ANDA	Current
61919-668	NABUMETONE	NABUMETONE	Direct_Rx	ANDA	Current
61919-698	NABUMETONE	NABUMETONE	Direct_Rx	ANDA	Current
61919-698	NABUMETONE	NABUMETONE	Direct_Rx	ANDA	Current
63187-378	Nabumetone	Nabumetone	Proficient Rx LP	ANDA	Current
63187-378	Nabumetone	Nabumetone	Proficient Rx LP	ANDA	Current
63187-484	Nabumetone	Nabumetone	Proficient Rx LP	ANDA	Current
63187-484	Nabumetone	Nabumetone	Proficient Rx LP	ANDA	Current
63629-2682	Nabumetone	Nabumetone	Bryant Ranch Prepack	ANDA	Current
63629-2682	Nabumetone	Nabumetone	Bryant Ranch Prepack	ANDA	Current
66267-482	Nabumetone	Nabumetone	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-482	Nabumetone	Nabumetone	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-482	Nabumetone	Nabumetone	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-482	Nabumetone	Nabumetone	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-529	Nabumetone	Nabumetone	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-529	Nabumetone	Nabumetone	NuCare Pharmaceuticals, Inc.	ANDA	Current
66336-316	Nabumetone	Nabumetone	Dispensing Solutions, Inc.	ANDA	Current
68462-358	Nabumetone	Nabumetone	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-359	Nabumetone	Nabumetone	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-9908	Nabumetone	Nabumetone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9908	Nabumetone	Nabumetone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9908	Nabumetone	Nabumetone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9909	Nabumetone	Nabumetone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9909	Nabumetone	Nabumetone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9909	Nabumetone	Nabumetone	Preferred Pharmaceuticals, Inc.	ANDA	Current
69097-965	Nabumetone	Nabumetone	Cipla USA Inc.	ANDA	Current
69097-965	Nabumetone	Nabumetone	Cipla USA Inc.	ANDA	Current
69097-965	Nabumetone	Nabumetone	Cipla USA Inc.	ANDA	Current
69097-966	Nabumetone	Nabumetone	Cipla USA Inc.	ANDA	Current
69097-966	Nabumetone	Nabumetone	Cipla USA Inc.	ANDA	Current
69097-966	Nabumetone	Nabumetone	Cipla USA Inc.	ANDA	Current
70518-0934	Nabumetone	Nabumetone	REMEDYREPACK INC.	ANDA	Current
70518-0934	Nabumetone	Nabumetone	REMEDYREPACK INC.	ANDA	Current
70518-0934	Nabumetone	Nabumetone	REMEDYREPACK INC.	ANDA	Current