Details for New Drug Application (NDA): 201506
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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 201506
Tradename: | VALACYCLOVIR HYDROCHLORIDE |
Applicant: | Jubilant Generics |
Ingredient: | valacyclovir hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201506
Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 201506
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 201506 | ANDA | RPK Pharmaceuticals, Inc. | 53002-0060 | 53002-0060-0 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-0060-0) |
VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 201506 | ANDA | RPK Pharmaceuticals, Inc. | 53002-0060 | 53002-0060-1 | 2 TABLET, FILM COATED in 1 BOTTLE (53002-0060-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Apr 3, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1GM BASE | ||||
Approval Date: | Apr 3, 2012 | TE: | AB | RLD: | No |
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