Details for New Drug Application (NDA): 213306
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NDA 213306 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 twenty 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 213306
| Tradename: | VALGANCICLOVIR HYDROCHLORIDE |
| Applicant: | Granules |
| Ingredient: | valganciclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213306
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 213306
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 213306 | ANDA | Granules Pharmaceuticals Inc. | 70010-051 | 70010-051-40 | 100 mL in 1 BOTTLE (70010-051-40) |
| VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 213306 | ANDA | Somerset Therapeutics, LLC | 70069-810 | 70069-810-01 | 100 mL in 1 BOTTLE (70069-810-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 50MG/ML | ||||
| Approval Date: | Jan 31, 2020 | TE: | AB | RLD: | No | ||||
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