Details for New Drug Application (NDA): 020757
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NDA 020757 describes AVAPRO, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the AVAPRO profile page.
The generic ingredient in AVAPRO is irbesartan. There are thirty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the irbesartan profile page.
The generic ingredient in AVAPRO is irbesartan. There are thirty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the irbesartan profile page.
Summary for 020757
| Tradename: | AVAPRO |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | irbesartan |
| Patents: | 0 |
Pharmacology for NDA: 020757
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 020757
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AVAPRO | irbesartan | TABLET;ORAL | 020757 | NDA | Sanofi-Aventis U.S. LLC | 0024-5851 | 0024-5851-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0024-5851-30) |
| AVAPRO | irbesartan | TABLET;ORAL | 020757 | NDA | Sanofi-Aventis U.S. LLC | 0024-5852 | 0024-5852-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Sep 30, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Sep 30, 1997 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Sep 30, 1997 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020757
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-003 | Sep 30, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-001 | Sep 30, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-003 | Sep 30, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-002 | Sep 30, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-002 | Sep 30, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-001 | Sep 30, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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