Details for New Drug Application (NDA): 074311
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NDA 074311 describes TRIFLURIDINE, which is a drug marketed by Hikma and Sandoz and is included in two NDAs. It is available from one supplier. Additional details are available on the TRIFLURIDINE profile page.
The generic ingredient in TRIFLURIDINE is trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trifluridine profile page.
The generic ingredient in TRIFLURIDINE is trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trifluridine profile page.
Summary for 074311
| Tradename: | TRIFLURIDINE |
| Applicant: | Sandoz |
| Ingredient: | trifluridine |
| Patents: | 0 |
Pharmacology for NDA: 074311
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 074311
Suppliers and Packaging for NDA: 074311
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIFLURIDINE | trifluridine | SOLUTION/DROPS;OPHTHALMIC | 074311 | ANDA | Sandoz Inc | 61314-044 | 61314-044-75 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-044-75) / 7.5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Oct 6, 1995 | TE: | AT | RLD: | No | ||||
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