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 43.

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 · 129 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	A074201-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074201-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074201-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074201-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074201-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074201-003	AB	1	`84e616aacf4f…`
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…`

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 4 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAPROXEN	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	a9f9ce81-9d51-4167-9581-974866a8fe31	2025-10-17	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	e0f430fd-4511-41c8-b5e9-894abe4f3c37	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	cfa88511-40bb-4658-b606-44c68d0746b7	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	b500bdba-946a-41ff-855c-1f2937547d01	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Aurobindo Pharma Limited	570974d4-0d5b-4df2-b307-37380511835d	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	2d01e583-670a-46f4-b5f2-3fad46d0376f	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	124af155-0661-4054-9800-de547d8212d7	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Zameer Pharmaceuticals LLC	d2e5553a-7c90-407c-9f07-3be65560c23a	2025-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	29d98cf3-a0f2-3f89-e054-00144ff88e88	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	6573681e-e9be-440f-a818-a533b744648e	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Proficient Rx LP	e64b3b36-f96e-463e-aca8-8f6e86724bcf	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Aurobindo Pharma Limited	0e5315bc-c02f-4749-be69-b5b528327d58	2025-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Amneal Pharmaceuticals LLC	c43a43e2-e867-448d-8f59-3efc7c077cbc	2025-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN SODIUM	DISCOUNT DRUG MART	c1dce2e4-ad7a-4462-a775-9a5bcb2375ed	2025-05-15	Warnings	Name fallback brand name: NAPROXEN
NAPROXEN	NAPROXEN SODIUM	DISCOUNT DRUG MART	a0c67043-1e78-4eac-86e6-497b4364651a	2025-05-15	Warnings	Name fallback brand name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	7fef9311-471b-472c-b4f2-c952a2b3a255	2025-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Camber Pharmaceuticals, Inc.	fd5e8d84-f92c-4f4b-ab0d-4cda7cf826bd	2025-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Coupler LLC	3375e139-d9de-8c2d-e063-6394a90a653d	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	e63a034d-23ef-458f-88ed-8b6d73699621	2025-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Asclemed USA, Inc.	1e406e47-408a-48cc-921e-52882a11581c	2025-04-11	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 · 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