Application 202807

Type: ANDA
Sponsor: CATALENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	CAPSULE;ORAL	EQ 200MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202807-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL			2019-01-04

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A202807-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2019-01-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202807-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2019-01-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202807-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2019-01-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202807-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2019-01-04	`a50c72e98297…`

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	P & L Development, LLC	3bd60171-c073-441a-8d59-c85efee69e07	2025-11-17	Warnings	Exact identifier application applno (ANDA): 202807 application number: ANDA202807 ndc (product): 59726-751
Naproxen Sodium	NAPROXEN SODIUM	Walgreens	a380cace-43dc-4b9c-84d3-0b38241d9d2e	2022-03-30	Warnings	Exact identifier application applno (ANDA): 202807 application number: ANDA202807 ndc (product): 0363-7510

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-7510	Naproxen Sodium	Naproxen Sodium	Walgreens	ANDA	Current
0363-7510	Naproxen Sodium	Naproxen Sodium	Walgreens	ANDA	Current
55910-851	Naproxen Sodium	Naproxen Sodium	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
59726-751	Naproxen Sodium	Naproxen Sodium	P & L Development, LLC	ANDA	Current
59726-751	Naproxen Sodium	Naproxen Sodium	P & L Development, LLC	ANDA	Current