Details for New Drug Application (NDA): 079012
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NDA 079012 describes VALACYCLOVIR HYDROCHLORIDE, which is a drug marketed by Aiping Pharm Inc, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hetero Labs Ltd V, Hikma, Jubilant Generics, Mylan Pharms Inc, Pharmobedient, Rising, Sun Pharm Inds Ltd, Teva Pharms, Watson Labs Inc, Yiling, and Zydus Lifesciences, and is included in sixteen NDAs. It is available from thirty-nine 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 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 suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
Summary for 079012
| Tradename: | VALACYCLOVIR HYDROCHLORIDE |
| Applicant: | Rising |
| Ingredient: | valacyclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 079012
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 079012
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 079012 | ANDA | TIME CAP LABORATORIES, INC. | 49483-690 | 49483-690-03 | 30 TABLET in 1 BOTTLE (49483-690-03) |
| VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 079012 | ANDA | TIME CAP LABORATORIES, INC. | 49483-690 | 49483-690-04 | 10 TABLET in 1 BLISTER PACK (49483-690-04) |
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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