Details for New Drug Application (NDA): 204750
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NDA 204750 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Granules, Hetero Labs Ltd V, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Norvium Bioscience, Somerset Theraps Llc, and Strides Pharma, and is included in sixteen NDAs. It is available from nineteen suppliers. Additional details are available on the VALGANCICLOVIR HYDROCHLORIDE profile page.
The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 204750
| Tradename: | VALGANCICLOVIR HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | valganciclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204750
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 204750
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 204750 | ANDA | Aurobindo Pharma Limited | 65862-753 | 65862-753-01 | 100 TABLET in 1 BOTTLE (65862-753-01) |
| VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 204750 | ANDA | Aurobindo Pharma Limited | 65862-753 | 65862-753-05 | 500 TABLET in 1 BOTTLE (65862-753-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 450MG BASE | ||||
| Approval Date: | Mar 31, 2016 | TE: | AB | RLD: | No | ||||
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