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Details for New Drug Application (NDA): 018299
NDA 018299 describes VIROPTIC, which is a drug marketed by Monarch Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the VIROPTIC profile page.
The generic ingredient in VIROPTIC is trifluridine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the trifluridine profile page.
The generic ingredient in VIROPTIC is trifluridine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the trifluridine profile page.
Summary for 018299
| Tradename: | VIROPTIC |
| Applicant: | Monarch Pharms |
| Ingredient: | trifluridine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018299
| Ingredient-type | Nucleoside Analog |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 018299
Suppliers and Packaging for NDA: 018299
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIROPTIC | trifluridine | SOLUTION/DROPS;OPHTHALMIC | 018299 | NDA | Pfizer Laboratories Div Pfizer Inc | 61570-037 | 61570-037-75 | 1 BOTTLE, DROPPER in 1 CARTON (61570-037-75) > 7.5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
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