Details for New Drug Application (NDA): 021003
✉ Email this page to a colleague
The generic ingredient in EPIVIR-HBV is lamivudine. There are twenty-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lamivudine profile page.
Summary for 021003
Tradename: | EPIVIR-HBV |
Applicant: | Glaxosmithkline |
Ingredient: | lamivudine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021003
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021003
Suppliers and Packaging for NDA: 021003
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003 | NDA | GlaxoSmithKline LLC | 0173-0662 | 0173-0662-00 | 60 TABLET, FILM COATED in 1 BOTTLE (0173-0662-00) |
EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-478 | 66993-478-60 | 60 TABLET, FILM COATED in 1 BOTTLE (66993-478-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 8, 1998 | TE: | RLD: | Yes |
Expired US Patents for NDA 021003
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription