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Details for New Drug Application (NDA): 202051
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The generic ingredient in ADEFOVIR DIPIVOXIL is adefovir dipivoxil. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.
Summary for 202051
Tradename: | ADEFOVIR DIPIVOXIL |
Applicant: | Sigmapharm Labs Llc |
Ingredient: | adefovir dipivoxil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202051
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 202051
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ADEFOVIR DIPIVOXIL | adefovir dipivoxil | TABLET;ORAL | 202051 | ANDA | Sigmapharm Laboratories, LLC | 42794-003 | 42794-003-08 | 1 BOTTLE in 1 CARTON (42794-003-08) > 30 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 29, 2013 | TE: | AB | RLD: | No |
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