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 5 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Bryant Ranch Prepack	9d7bc470-fbba-40a6-a56c-f681a3cee9cf	2025-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	727913f6-9542-4a2d-9318-4b7ff521bffd	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Amneal Pharmaceuticals of New York LLC	2718e0b7-1ce6-457e-bee9-11b634dfd353	2025-03-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	ANI Pharmaceuticals, Inc.	052e6fe3-d619-42c3-b64e-67c7aaf7271c	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN SODIUM	Geri-Care Pharmaceutical Corp	9a61d544-e46d-6703-e053-2a95a90a32fd	2025-02-27	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN SODIUM	NuCare Pharmaceuticals,Inc.	f1ed8384-83d6-6f2a-e053-2a95a90ab08f	2025-02-04	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN SODIUM	Bryant Ranch Prepack	f9ddc614-26b7-48dc-ae93-02da6388f2d5	2025-01-30	Warnings	Name fallback brand name: Naproxen
Naproxen	NAPROXEN	Direct_Rx	f499a207-02c8-a338-e053-2995a90accc0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN	DIRECT RX	b1b78c49-82e9-2402-e053-2a95a90ae35f	2025-01-17	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9ad850-57b5-a21d-e053-2a95a90ae68e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9a94a8-3825-eabd-e053-2a95a90acd58	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9a96cf-1cda-8ace-e053-2a95a90a18cc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9ac948-4405-5abf-e053-2995a90af2b5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9aa7a0-e287-5935-e053-2995a90a1d11	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Advanced Rx Pharmacy of Tennessee, LLC	d292f376-1844-b01c-e053-2a95a90a0927	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Quality Care Products, LLC	1acfb8cc-6faf-4b3e-9304-4819c42de0a6	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Hikma Pharmaceuticals USA Inc.	a5757b1a-62c9-4421-9794-6fb121ce9b7e	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Amneal Pharmaceuticals NY LLC	985aedc1-8b3c-4cb4-af13-7203a2b57ab7	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	MARKSANS PHARMA LIMITED	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	da61463f-f87b-4aba-b538-7264252cadb8	2024-09-05	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