Details for New Drug Application (NDA): 021304
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NDA 021304 describes VALCYTE, which is a drug marketed by Cheplapharm and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the VALCYTE profile page.
The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 021304
| Tradename: | VALCYTE |
| Applicant: | Cheplapharm |
| Ingredient: | valganciclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021304
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 021304
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304 | NDA | H2-Pharma, LLC | 61269-480 | 61269-480-60 | 1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 450MG BASE | ||||
| Approval Date: | Mar 29, 2001 | TE: | AB | RLD: | Yes | ||||
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