Details for New Drug Application (NDA): 020564
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The generic ingredient in EPIVIR 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 020564
Tradename: | EPIVIR |
Applicant: | Viiv Hlthcare |
Ingredient: | lamivudine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020564
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 020564
Suppliers and Packaging for NDA: 020564
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPIVIR | lamivudine | TABLET;ORAL | 020564 | NDA | ViiV Healthcare Company | 49702-203 | 49702-203-18 | 60 TABLET, FILM COATED in 1 BOTTLE (49702-203-18) |
EPIVIR | lamivudine | TABLET;ORAL | 020564 | NDA | ViiV Healthcare Company | 49702-204 | 49702-204-13 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-204-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Nov 17, 1995 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jun 24, 2002 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020564
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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