Application 075337

Type: ANDA
Sponsor: PLIVA

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
A075337-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL			1999-05-26
A075337-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL			1999-05-26

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	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		1999-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075337-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1999-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075337-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1999-05-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075337-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075337-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075337-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075337-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075337-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075337-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075337-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075337-002	AB	1	`ea99ee380514…`

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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8623	ORIG	1999-05-26