Application 207612

Type: ANDA
Sponsor: NOVELGENIX THERAPS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	TABLET;ORAL	220MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207612-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2018-11-16

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207612-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2018-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207612-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2018-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207612-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2018-11-16	`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 7 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aleve Headache Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	3ba28e47-1294-bec7-e063-6294a90ac80a	2025-08-05	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium Caplets	NAPROXEN SODIUM	Dr Reddy's Laboratories Inc	ee0463bc-e939-1ecf-5a86-d045c426fecf	2025-07-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
TopCare All Day Pain Relief	NAPROXEN SODIUM	Topco Associates LLC	079eccdd-33bd-4b5c-bf46-9aef78559082	2025-07-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium Headache Pain Caplets	NAPROXEN SODIUM	Dr.Reddy's Laboratories Inc	605ca130-88aa-27d5-330c-6d9c95987f1f	2025-07-22	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	SAM'S WEST INC	7a87a339-4482-ec9e-3c77-7ccb9cea2c4c	2025-07-22	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Kroger Company	30bcf289-0039-f389-73c4-fef3e8861034	2025-07-22	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
kirkland signature naproxen sodium	NAPROXEN SODIUM	Costco Wholesale Company	d63cd2ad-18cf-4379-b48e-a487334ad9cc	2025-07-16	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	AMERIFOODS TRADING COMPANY	f6dd2150-1643-18ff-e053-6294a90a422b	2025-07-15	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Marc Glassman, Inc.	684e03b6-74eb-4374-a512-1c01ea216b51	2025-07-15	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Marc Glassman, Inc.	eeda0edf-7054-42aa-af8e-4df38b918f81	2025-07-15	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	84b9e9a4-b805-420e-83be-ebe98776d1ee	2025-06-20	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
NAPROXEN SODIUM	NAPROXEN SODIUM	AAA Pharmaceutical, Inc.	5ea3217d-845d-4781-b849-6b00babdc214	2025-06-17	Warnings	Name fallback brand name: NAPROXEN SODIUM generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	FSA STORE INC.	f4326f99-142b-0b70-e053-2995a90ac951	2025-06-17	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen sodium	NAPROXEN SODIUM	Dr. Reddy's Laboratories Inc.	37de42a6-701b-7f6e-e631-519e2ea78b54	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen sodium generic name: NAPROXEN SODIUM
equaline naproxen sodium	NAPROXEN SODIUM	United Natural Foods, Inc. dba UNFI	1022d075-9bdf-46df-81ac-c84cb2608195	2025-06-04	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Dr.Reddy's Laboratories Limited	aca5d497-fbc6-464d-2dee-25c50e11bc78	2025-06-03	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM
Naproxen Sodium Headache Pain	NAPROXEN SODIUM	Dr.Reddy's Laboratories Inc	12e45b43-eca2-73f4-1d68-07d4238f8c70	2025-06-03	Warnings	Name fallback generic name: NAPROXEN SODIUM
AMAZON BASIC CARE NAPROXEN SODIUM	NAPROXEN SODIUM	Amazon.com Services LLC	10ee5bc0-509d-b549-e063-6394a90a5dca	2025-05-26	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium HEADACHE PAIN	NAPROXEN SODIUM	Aurohealth LLC	10464576-0f9a-4a64-a388-3afe33682938	2025-05-26	Warnings	Name fallback generic name: NAPROXEN SODIUM
Naproxen Sodium	NAPROXEN SODIUM	Aurohealth LLC	2dfa820c-5130-43b0-9e63-19354bbbd3c3	2025-05-26	Warnings	Name fallback brand name: Naproxen Sodium generic name: NAPROXEN SODIUM

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46994-661	NAPROXEN SODIUM	NAPROXEN SODIUM	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
46994-661	NAPROXEN SODIUM	NAPROXEN SODIUM	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
46994-661	NAPROXEN SODIUM	NAPROXEN SODIUM	SAVE-A-LOT FOOD STORES, LTD.	ANDA	Current
50090-4704	Naproxen sodium	Naproxen sodium	A-S Medication Solutions	ANDA	Current
50090-4704	Naproxen sodium	Naproxen sodium	A-S Medication Solutions	ANDA	Current
68210-4120	Naproxen Sodium	Naproxen Sodium	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4121	Naproxen Sodium	Naproxen Sodium	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4137	Naproxen Sodium	Naproxen Sodium	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4137	Naproxen Sodium	Naproxen Sodium	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4137	Naproxen Sodium	Naproxen Sodium	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4137	Naproxen Sodium	Naproxen Sodium	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4137	Naproxen Sodium	Naproxen Sodium	Spirit Pharmaceuticals LLC	ANDA	Current
69230-313	Naproxen sodium	Naproxen sodium	Camber Consumer Care	ANDA	Current
72090-003	Pain and Fever Relief	Naproxen Sodium	Pioneer Life Sciences, LLC	ANDA	Current