Details for New Drug Application (NDA): 203047
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NDA 203047 describes VALACYCLOVIR HYDROCHLORIDE, which is a drug marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hetero Labs Ltd V, Hikma, Jubilant Generics, Mylan Pharms Inc, Pharmobedient, Rising, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Watson Labs Inc, Yiling, and Zydus Lifesciences, and is included in sixteen NDAs. It is available from forty suppliers. Additional details are available on the VALACYCLOVIR HYDROCHLORIDE profile page.
The generic ingredient in VALACYCLOVIR HYDROCHLORIDE is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
The generic ingredient in VALACYCLOVIR HYDROCHLORIDE is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
Summary for 203047
| Tradename: | VALACYCLOVIR HYDROCHLORIDE |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | valacyclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203047
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 203047
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 203047 | ANDA | Camber Pharmaceuticals, Inc. | 31722-704 | 31722-704-01 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-704-01) |
| VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 203047 | ANDA | Camber Pharmaceuticals, Inc. | 31722-704 | 31722-704-05 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-704-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Apr 8, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1GM BASE | ||||
| Approval Date: | Apr 8, 2015 | TE: | AB | RLD: | No | ||||
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