Application 074201

Type: ANDA
Sponsor: TEVA

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 42.

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
A074201-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21
A074201-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21
A074201-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074201-001	AB
A074201-002	AB
A074201-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A074201-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074201-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074201-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074201-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074201-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074201-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074201-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074201-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074201-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074201-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074201-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074201-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074201-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074201-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074201-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074201-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074201-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074201-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074201-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074201-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074201-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074201-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074201-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074201-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074201-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074201-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074201-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074201-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074201-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074201-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074201-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074201-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074201-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074201-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074201-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074201-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074201-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074201-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074201-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074201-001	AB	1	`1e350fbaab3a…`

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 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Sportpharm LLC	1c5b2bc1-26bb-4f88-bded-399263c82331	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	f18181f4-6b14-48a8-a149-e45b3360a250	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Cameron Pharmaceuticals	2ae474dd-eaae-4401-8d42-613d672daea0	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	97d6c4ef-13b1-4b0b-a15a-f0590019940d	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	852fed15-e78b-47a8-aeb4-623dfe1edad9	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	REMEDYREPACK INC.	6bb65680-76ea-46e5-ae70-f3091e360368	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	REMEDYREPACK INC.	12202ef3-c65e-45a6-88ed-5d945d8fd41c	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Radha Pharmaceuticals, Inc.	1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	AvPAK	e6fbf8f1-b064-658d-17bb-e7d6320aa45f	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	ScieGen Pharmaceuticals, Inc.	81e22c1f-f94d-46e9-8b7d-72dc2518319e	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	NuCare Pharmaceuticals,Inc.	c136cf75-4ad4-8634-e053-2a95a90a53a4	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Aurobindo Pharma Limited	67815abd-5e97-4ccb-ac9b-28c2ef6123e7	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	4e97e645-552d-424b-990a-f94349a86f17	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	000155a8-709c-44e5-a75f-cd890f3a7caf	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	d06db628-f6f0-48e2-b538-69c0837c49e3	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	9d28422f-6f25-4f14-9272-e0907c971f33	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
BACK AND MUSCLE PAIN	NAPROXEN	WALGREENS	81417810-8a34-c859-e053-2a91aa0a6507	2026-01-26	Warnings	Name fallback generic name: NAPROXEN
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	87acd650-ea8a-4396-be72-5568c4b1755c	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Acella Pharmaceuticals, LLC	7e6f03fb-4b36-4418-9684-f45637abbb78	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	fa2fe6fd-c476-dd29-e053-6294a90a9e9e	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1504	Naproxen	Naproxen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-3562	Naproxen	Naproxen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-3563	Naproxen	Naproxen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7709	Naproxen	Naproxen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-010	Naproxen	Naproxen	Blenheim Pharmacal, Inc.	ANDA	Current
35356-684	Naproxen	Naproxen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
53808-0739	Naproxen	NAPROXEN	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0742	Naproxen Sodium	NAPROXEN SODIUM	State of Florida DOH Central Pharmacy	ANDA	Current
67296-0708	Naproxen	Naproxen	RedPharm Drug, Inc.	ANDA	Current
67296-0708	Naproxen	Naproxen	RedPharm Drug, Inc.	ANDA	Current