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Details for New Drug Application (NDA): 202051
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NDA 202051 describes ADEFOVIR DIPIVOXIL, which is a drug marketed by Apotex and Sigmapharm Labs Llc and is included in two NDAs. It is available from two suppliers. Additional details are available on the ADEFOVIR DIPIVOXIL profile page.
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.
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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