Details for New Drug Application (NDA): 202501
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NDA 202501 describes CIDOFOVIR, which is a drug marketed by Avet Lifesciences and Mylan Institutional and is included in two NDAs. It is available from two suppliers. Additional details are available on the CIDOFOVIR profile page.
The generic ingredient in CIDOFOVIR is cidofovir. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cidofovir profile page.
The generic ingredient in CIDOFOVIR is cidofovir. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cidofovir profile page.
Summary for 202501
| Tradename: | CIDOFOVIR |
| Applicant: | Avet Lifesciences |
| Ingredient: | cidofovir |
| Patents: | 0 |
Pharmacology for NDA: 202501
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 202501
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIDOFOVIR | cidofovir | INJECTABLE;INJECTION | 202501 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-216 | 23155-216-31 | 5 mL in 1 VIAL, GLASS (23155-216-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 75MG BASE/ML | ||||
| Approval Date: | Jul 26, 2012 | TE: | AP | RLD: | No | ||||
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