Details for New Drug Application (NDA): 050662
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NDA 050662 describes BIAXIN, which is a drug marketed by Abbvie and is included in three NDAs. Additional details are available on the BIAXIN profile page.
The generic ingredient in BIAXIN is clarithromycin. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
The generic ingredient in BIAXIN is clarithromycin. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
Summary for 050662
| Tradename: | BIAXIN |
| Applicant: | Abbvie |
| Ingredient: | clarithromycin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050662
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 31, 1991 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 31, 1991 | TE: | RLD: | Yes | |||||
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