Details for New Drug Application (NDA): 078518
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NDA 078518 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 078518
| Tradename: | VALACYCLOVIR HYDROCHLORIDE |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | valacyclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078518
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 078518
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 078518 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4275 | 0378-4275-77 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-77) |
| VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 078518 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4275 | 0378-4275-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-93) |
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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