← FDA Drug Approvals (Drugs@FDA)
VALCYTE
NDA · New Drug Application · Sponsor: CHEPLAPHARM · Approved 2009-08-28
Drug application
- FDA Application #
NDA022257
- Application type
- New Drug Application
- Brand name
- VALCYTE
- Generic name
- VALGANCICLOVIR HYDROCHLORIDE
- Active ingredients
- VALGANCICLOVIR HYDROCHLORIDE
- Dosage form
- FOR SOLUTION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- CHEPLAPHARM
- Manufacturer
- H2-Pharma, LLC
- First approval
- 2009-08-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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