Details for New Drug Application (NDA): 021304
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The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty-four 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 |
Formulation / Manufacturing: | see details |
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 | Genentech, Inc. | 0004-0038 | 0004-0038-22 | 1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
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 |
Expired US Patents for NDA 021304
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | VALCYTE | valganciclovir hydrochloride | TABLET;ORAL | 021304-001 | Mar 29, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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