Details for New Drug Application (NDA): 065489
NDA 065489 describes CLARITHROMYCIN, which is a drug marketed by Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Lupin, Mpp Pharma, Ranbaxy, Sunshine, Alembic, Aurobindo, Chartwell, Hec Pharm, Hikma, Ivax Sub Teva Pharms, Jubilant Cadista, Novitium Pharma, Pharmobedient, Teva, and Wockhardt, and is included in twenty-three NDAs. It is available from twenty-six suppliers. Additional details are available on the CLARITHROMYCIN profile page.
The generic ingredient in CLARITHROMYCIN is clarithromycin. There is one drug master file entry for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
The generic ingredient in CLARITHROMYCIN is clarithromycin. There is one drug master file entry for this compound. Twenty-six 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 |
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 | ||||
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