Details for New Drug Application (NDA): 065489
✉ Email this page to a colleague
The generic ingredient in CLARITHROMYCIN is clarithromycin. There are twenty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
Summary for 065489
Tradename: | CLARITHROMYCIN |
Applicant: | Aurobindo |
Ingredient: | clarithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065489
Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 065489
Suppliers and Packaging for NDA: 065489
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 065489 | ANDA | Major Pharmaceuticals | 0904-6872 | 0904-6872-04 | 30 BLISTER PACK in 1 CARTON (0904-6872-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 065489 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-823 | 43063-823-20 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jul 25, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jul 25, 2012 | TE: | AB | RLD: | No |
Complete Access Available with Subscription