Application 216504

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN	NAPROXEN	SUSPENSION;ORAL	25MG/ML	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
A216504-001	NAPROXEN	NAPROXEN	25MG/ML	SUSPENSION / ORAL			2025-10-03

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.

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	A216504-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL		2025-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216504-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL		2025-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216504-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216504-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	2025-10-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216504-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL		2025-10-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216504-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216504-001	AB	1	`31067a03dcf5…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Aurobindo Pharma Limited	570974d4-0d5b-4df2-b307-37380511835d	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216504 application number: ANDA216504

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.