Details for New Drug Application (NDA): 077478
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The generic ingredient in VALACYCLOVIR HYDROCHLORIDE 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 077478
Tradename: | VALACYCLOVIR HYDROCHLORIDE |
Applicant: | Sandoz |
Ingredient: | valacyclovir hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077478
Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 077478
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 077478 | ANDA | Sandoz Inc. | 0781-5208 | 0781-5208-01 | 100 TABLET in 1 BOTTLE (0781-5208-01) |
VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 077478 | ANDA | Sandoz Inc. | 0781-5208 | 0781-5208-05 | 500 TABLET in 1 BOTTLE (0781-5208-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | May 24, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1GM BASE | ||||
Approval Date: | May 24, 2010 | TE: | AB | RLD: | No |
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