Application 078250

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN	NAPROXEN	TABLET;ORAL	250MG	No	No
002	NAPROXEN	NAPROXEN	TABLET;ORAL	375MG	No	No
003	NAPROXEN	NAPROXEN	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078250-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28
A078250-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28
A078250-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078250-001	AB
A078250-002	AB
A078250-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078250-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078250-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078250-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078250-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078250-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078250-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078250-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078250-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078250-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078250-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078250-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078250-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-001	AB	1	`79d66fd596c7…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Proficient Rx LP	96601d76-50ea-4dc0-b588-d174f8d8bb51	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Proficient Rx LP	3e4e5371-d796-47c7-95c1-d99e82a0b282	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	3e14f839-d1e4-44df-a457-29f005b3e62e	2020-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250

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 2 of 3 · 173 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63874-326	Naproxen	Naproxen	Altura Pharmaceuticals, Inc.	ANDA	Current
66267-151	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-151	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-152	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-152	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-153	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-153	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-153	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-806	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-806	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-807	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-807	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-807	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
67046-499	Naproxen	Naproxen	Contract Pharmacy Services-PA	ANDA	Current
67046-500	Naproxen	Naproxen	Contract Pharmacy Services-PA	ANDA	Current
67046-501	Naproxen	Naproxen	Contract Pharmacy Services-PA	ANDA	Current
67296-0406	Naproxen	Naproxen	RedPharm Drug, Inc.	ANDA	Current
67296-0406	Naproxen	Naproxen	RedPharm Drug, Inc.	ANDA	Current
67296-0406	Naproxen	Naproxen	RedPharm Drug, Inc.	ANDA	Current
68071-2245	Naproxen	Naproxen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2245	Naproxen	Naproxen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2245	Naproxen	Naproxen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3092	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3092	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3092	Naproxen	Naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
68151-2895	Naproxen	Naproxen	Carilion Materials Management	ANDA	Current
68462-188	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-188	Naproxen	Naproxen	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-188	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-188	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-188	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-189	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-189	Naproxen	Naproxen	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-189	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-189	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-189	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-190	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-190	Naproxen	Naproxen	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-190	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-190	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68462-190	Naproxen	Naproxen	Glenmark Pharmaceuticals Limited Inc., USA	ANDA	Current
68788-6842	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6842	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6842	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9151	Naproxen	Naproxen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9151	Naproxen	Naproxen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9151	Naproxen	Naproxen	Preferred Pharmaceuticals, Inc.	ANDA	Current
69036-221	SALLUS Pain Relief Collection with Naproxen	Naproxen	Sallus Laboratories, Llc	ANDA	Current
69677-171	Naproxen	Naproxen	MAS MANAGEMENT GROUP, INC.	ANDA	Current
70518-0208	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0208	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0208	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0208	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0208	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0208	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0208	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0208	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0636	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0636	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0636	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0636	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0807	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0807	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0807	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0807	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1450	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1450	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1450	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1450	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1450	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1450	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1516	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current