Details for New Drug Application (NDA): 020485
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NDA 020485 describes VISINE, which is a drug marketed by Johnson And Johnson and is included in two NDAs. It is available from one supplier. Additional details are available on the VISINE profile page.
The generic ingredient in VISINE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
The generic ingredient in VISINE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 020485
| Tradename: | VISINE |
| Applicant: | Johnson And Johnson |
| Ingredient: | naphazoline hydrochloride; pheniramine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020485
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VISINE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 020485 | NDA | Kenvue Brands LLC | 69968-0367 | 69968-0367-1 | 1 BOTTLE in 1 CARTON (69968-0367-1) / 15 mL in 1 BOTTLE |
| VISINE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 020485 | NDA | Kenvue Brands LLC | 69968-0367 | 69968-0367-2 | 2 BOTTLE in 1 CARTON (69968-0367-2) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.025%;0.3% | ||||
| Approval Date: | Jan 31, 1996 | TE: | RLD: | Yes | |||||
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