Details for New Drug Application (NDA): 218838
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NDA 218838 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Granules, Hetero Labs Ltd V, Micro Labs, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Pharmobedient, Somerset Theraps Llc, Sph Zhongxi Pharm, and Strides Pharma Intl, and is included in eighteen 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 is one drug master file entry for this compound. Twenty 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 is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 218838
| Tradename: | VALGANCICLOVIR HYDROCHLORIDE |
| Applicant: | Micro Labs |
| Ingredient: | valganciclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218838
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 218838
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 218838 | ANDA | Micro Labs Limited | 42571-477 | 42571-477-47 | 1 BOTTLE in 1 CARTON (42571-477-47) / 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 50MG/ML | ||||
| Approval Date: | Mar 19, 2026 | TE: | AB | RLD: | No | ||||
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