Details for New Drug Application (NDA): 020564
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NDA 020564 describes EPIVIR, which is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. It is available from one supplier. Additional details are available on the EPIVIR profile page.
The generic ingredient in EPIVIR is lamivudine. There are twenty-nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the lamivudine profile page.
The generic ingredient in EPIVIR is lamivudine. There are twenty-nine drug master file entries for this compound. Fifteen 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 |
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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | ⤷ Get Started Free | ⤷ Get Started Free |
| Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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