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Details for New Drug Application (NDA): 021449
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The generic ingredient in HEPSERA 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 021449
Tradename: | HEPSERA |
Applicant: | Gilead |
Ingredient: | adefovir dipivoxil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021449
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 021449
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449 | NDA | Gilead Sciences, Inc. | 61958-0501 | 61958-0501-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-0501-1) |
Paragraph IV (Patent) Challenges for 021449
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
HEPSERA | TABLET;ORAL | adefovir dipivoxil | 021449 | 2010-06-08 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 20, 2002 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021449
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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