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Details for New Drug Application (NDA): 021071
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NDA 021071 describes AVANDIA, which is a drug marketed by Sb Pharmco and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the AVANDIA profile page.
The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rosiglitazone maleate profile page.
The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rosiglitazone maleate profile page.
Summary for 021071
| Tradename: | AVANDIA |
| Applicant: | Sb Pharmco |
| Ingredient: | rosiglitazone maleate |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021071
| Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
Suppliers and Packaging for NDA: 021071
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071 | NDA | GlaxoSmithKline LLC | 0173-0861 | 0173-0861-18 | 60 TABLET, FILM COATED in 1 BOTTLE (0173-0861-18) |
| AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071 | NDA | GlaxoSmithKline LLC | 0173-0863 | 0173-0863-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0863-13) |
Paragraph IV (Patent) Challenges for 021071
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AVANDIA | TABLET;ORAL | rosiglitazone maleate | 021071 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | May 25, 1999 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 19, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | May 25, 1999 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 19, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | May 25, 1999 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 19, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021071
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-003 | May 25, 1999 | Start Trial | Start Trial |
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-004 | May 25, 1999 | Start Trial | Start Trial |
| Sb Pharmco | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-002 | May 25, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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