|
8-4
|
阿德福韦酯片
|
Adefovir Dipivoxil Tablets/Hepsera
|
10mg
|
片剂
|
GILEAD SCIENCES INC
|
美国橙皮书
|
|
Action Date |
Submission |
Action Type |
Submission Classification |
Review Priority; Orphan Status |
Letters, Reviews, Labels, Patient Package Insert |
Notes |
|
09/20/2002 |
ORIG-1 |
Approval |
Type 1 - New Molecular Entity |
PRIORITY |
Label (PDF)
Letter (PDF)
Review |
New Drug Application (NDA): 021449
Company: GILEAD
|
Drug Name |
Active Ingredients |
Strength |
Dosage Form/Route |
Marketing Status |
TE Code |
RLD |
RS |
|
HEPSERA |
ADEFOVIR DIPIVOXIL |
10MG |
TABLET;ORAL |
Prescription |
AB |
Yes |
Yes |
NDC Code(s): 61958-0501-1
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60adac4-57c2-4089-aefc-1a77a48676fc
Hepsera (Adefovir Dipivoxil) Tablets
Company: Gilead Sciences, Inc.
Application No.: 21-449
Approval Date: 9/20/2002
