Details for New Drug Application (NDA): 079137
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NDA 079137 describes VALACYCLOVIR HYDROCHLORIDE, which is a drug marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Graviti Pharms, Hetero Labs Ltd V, Hikma, Jubilant Generics, Mylan Pharms Inc, Norvium Bioscience, 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-two 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-two suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
Summary for 079137
| Tradename: | VALACYCLOVIR HYDROCHLORIDE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | valacyclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 079137
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 079137
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 079137 | ANDA | Zydus Lifesciences Limited | 65841-629 | 65841-629-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-629-01) |
| VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 079137 | ANDA | Zydus Lifesciences Limited | 65841-629 | 65841-629-06 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-629-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Dec 29, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1GM BASE | ||||
| Approval Date: | Dec 29, 2017 | TE: | AB | RLD: | No | ||||
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