Details for New Drug Application (NDA): 201276
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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 | INJECTABLE;INJECTION | 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: | INJECTABLE;INJECTION | Strength | EQ 75MG BASE/ML | ||||
Approval Date: | Jun 27, 2012 | TE: | AP | RLD: | No |
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