Details for New Drug Application (NDA): 020487
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NDA 020487 describes VALTREX, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers. Additional details are available on the VALTREX profile page.
The generic ingredient in VALTREX is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
The generic ingredient in VALTREX is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
Summary for 020487
| Tradename: | VALTREX |
| Applicant: | Glaxosmithkline |
| Ingredient: | valacyclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020487
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 020487
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487 | NDA | GlaxoSmithKline LLC | 0173-0565 | 0173-0565-04 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04) |
| VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487 | NDA | GlaxoSmithKline LLC | 0173-0565 | 0173-0565-10 | 90 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Jun 23, 1995 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1GM BASE | ||||
| Approval Date: | Jun 23, 1995 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020487
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487-002 | Jun 23, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487-002 | Jun 23, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487-001 | Jun 23, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487-001 | Jun 23, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487-001 | Jun 23, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487-001 | Jun 23, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VALTREX | valacyclovir hydrochloride | TABLET;ORAL | 020487-002 | Jun 23, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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