Application 080229

Type: ANDA
Sponsor: ALCON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPHCON FORTE	NAPHAZOLINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	0.1%	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
A080229-001	NAPHCON FORTE	NAPHAZOLINE HYDROCHLORIDE	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A080229-001	NAPHCON FORTE	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080229-001	NAPHCON FORTE	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080229-001	NAPHCON FORTE	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pi Yuan Chin	NAPHAZOLINE HYDROCHLORIDE	International Nature Nutraceuticals	e7aedab9-da4c-4494-a896-1e6ed2a956fe	2025-12-27	Warnings	Name fallback generic name: NAPHAZOLINE HYDROCHLORIDE
NAFASOLINA	NAPHAZOLINE HYDROCHLORIDE	Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals	30cade3d-208f-8594-e063-6394a90ad2a0	2025-12-18	Warnings	Name fallback generic name: NAPHAZOLINE HYDROCHLORIDE
Nazal	NAPHAZOLINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	4d4043f8-5ed3-4027-beb6-687db1308202	2023-12-06	Warnings	Name fallback generic name: NAPHAZOLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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