Application 075227

Type: ANDA
Sponsor: TEVA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075227-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		1998-06-30
A075227-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		1998-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075227-001	AB
A075227-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A075227-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075227-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075227-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075227-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075227-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075227-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075227-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075227-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075227-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075227-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075227-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075227-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075227-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075227-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075227-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075227-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075227-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075227-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075227-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075227-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075227-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075227-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075227-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075227-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075227-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075227-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075227-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075227-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075227-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075227-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075227-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075227-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075227-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075227-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075227-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075227-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075227-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075227-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075227-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075227-002	AB	1	`f41ea6bd6efb…`

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 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Coupler LLC	5954565a-d9bd-9e26-e063-6294a90a03cb	2026-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN SODIUM	L.N.K. International, Inc.	82412133-c11a-4905-a119-965f44de10b7	2026-08-17	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN	REMEDYREPACK INC.	88a548d1-97c0-46d0-825a-75ef689d6470	2026-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	24d44eb6-921e-4150-a6b2-81f42ced32ab	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	49a00870-f580-4eb9-a95d-48fa956f147f	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Preferred Pharmaceuticals, Inc.	9f026fd5-f996-4383-b528-841d38d3dab5	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	20eb9d9f-11df-464f-a1b0-949f8fda4042	2026-07-28	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	c5e52ddd-a909-487a-bb46-01ad35690665	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	HAWAII REPACK, INC.	888efc91-b4de-4691-b84c-fb871e7a6dfe	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	St. Mary's Medical Park Pharmacy	e3a3e5d2-2d1e-74d3-e053-2995a90a82bf	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Coupler LLC	545fe39a-4777-b149-e063-6394a90a53cf	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Coupler LLC	53e6519a-cb52-85e2-e063-6394a90abdcf	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	REMEDYREPACK INC.	ccd95dfc-9236-4707-a715-6a12c91519ff	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	ST. MARY'S MEDICAL PARK PHARMACY	e3a4ab4a-b109-eb5e-e053-2a95a90afddd	2026-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	d9c63e1f-c2ad-434b-8a21-7fff21b7477b	2026-06-03	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN	A-S Medication Solutions	c5c8b6fd-f3f5-4fed-823c-9a80386b27b1	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Coupler LLC	52b8e52e-73be-3423-e063-6294a90af6e0	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Redpharm Drug	52503536-593e-808b-e063-6294a90a737f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	0041b483-34db-49a6-8665-f87e286cd0b8	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	2e72de28-e62b-44e0-b17d-500d13e0bcc6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN

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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1005	Naproxen	Naproxen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1005	Naproxen	Naproxen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1005	Naproxen	Naproxen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1005	Naproxen	Naproxen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1006	Naproxen	Naproxen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1006	Naproxen	Naproxen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1006	Naproxen	Naproxen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1006	Naproxen	Naproxen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
21695-343	Naproxen	Naproxen	Rebel Distributors Corp	ANDA	Current
33261-082	Naproxen	Naproxen	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-083	Naproxen	Naproxen	Aidarex Pharmaceuticals LLC	ANDA	Current
45865-867	Naproxen	Naproxen	medsource pharmaceuticals	ANDA	Current
45865-914	Naproxen	Naproxen	medsource pharmaceuticals	ANDA	Current
45865-914	Naproxen	Naproxen	medsource pharmaceuticals	ANDA	Current
49999-897	Naproxen	Naproxen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0608	Naproxen	Naproxen	A-S Medication Solutions	ANDA	Current
52959-516	Naproxen	Naproxen	H.J. Harkins Company, Inc.	ANDA	Current
55289-307	Naproxen	Naproxen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63629-3795	Naproxen	Naproxen	Bryant Ranch Prepack	ANDA	Current
68151-2609	Naproxen	Naproxen	Carilion Materials Management	ANDA	Current
68788-6908	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6908	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6908	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7072	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7072	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7072	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1064	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1064	Naproxen	Naproxen	REMEDYREPACK INC.	ANDA	Current
71205-469	Naproxen	Naproxen	Proficient Rx LP	ANDA	Current
71205-469	Naproxen	Naproxen	Proficient Rx LP	ANDA	Current
71205-469	Naproxen	Naproxen	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30804	ORIG	1998-06-30