Details for New Drug Application (NDA): 216317
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NDA 216317 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 216317
| Tradename: | VALGANCICLOVIR HYDROCHLORIDE |
| Applicant: | Appco |
| Ingredient: | valganciclovir hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216317
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 216317
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | FOR SOLUTION;ORAL | 216317 | ANDA | Florida Pharmaceutical Products, LLC | 71921-210 | 71921-210-12 | 1 BOTTLE in 1 CARTON (71921-210-12) / 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 50MG/ML | ||||
| Approval Date: | Apr 11, 2023 | TE: | AB | RLD: | No | ||||
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