Details for New Drug Application (NDA): 050775
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The generic ingredient in BIAXIN XL is clarithromycin. There are twenty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
Summary for 050775
| Tradename: | BIAXIN XL |
| Applicant: | Abbvie |
| Ingredient: | clarithromycin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050775
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 3, 2000 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 050775
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | BIAXIN XL | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 050775-001 | Mar 3, 2000 | 6,010,718 | ⤷ Get Started Free |
| Abbvie | BIAXIN XL | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 050775-001 | Mar 3, 2000 | 6,551,616 | ⤷ Get Started Free |
| Abbvie | BIAXIN XL | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 050775-001 | Mar 3, 2000 | 6,552,616 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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