Details for New Drug Application (NDA): 201276
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NDA 201276 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 201276
| Tradename: | CIDOFOVIR |
| Applicant: | Mylan Institutional |
| Ingredient: | cidofovir |
| Patents: | 0 |
Pharmacology for NDA: 201276
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 201276
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIDOFOVIR | cidofovir | SOLUTION;INTRAVENOUS | 201276 | ANDA | Mylan Institutional LLC | 67457-210 | 67457-210-05 | 1 VIAL, GLASS in 1 CARTON (67457-210-05) / 5 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 375MG BASE/5ML (EQ 75MG BASE/ML) | ||||
| Approval Date: | Jun 27, 2012 | TE: | AP | RLD: | No | ||||
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