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Details for New Drug Application (NDA): 021449
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NDA 021449 describes HEPSERA, which is a drug marketed by Gilead and is included in one NDA. It is available from one supplier. Additional details are available on the HEPSERA profile page.
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.
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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