Details for New Drug Application (NDA): 065384
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NDA 065384 describes CLARITHROMYCIN, which is a drug marketed by Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Lupin Ltd, Nostrum Labs Inc, Ranbaxy, Sunshine, Ajanta Pharma Ltd, Alembic, Aurobindo, Chartwell, Hec Pharm, Hikma, Ivax Sub Teva Pharms, Norvium Bioscience, Strides Pharma, Teva, and Wockhardt, and is included in twenty-three NDAs. It is available from twenty-eight suppliers. Additional details are available on the CLARITHROMYCIN profile page.
The generic ingredient in CLARITHROMYCIN 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 CLARITHROMYCIN 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 065384
| Tradename: | CLARITHROMYCIN |
| Applicant: | Chartwell |
| Ingredient: | clarithromycin |
| Patents: | 0 |
Pharmacology for NDA: 065384
| Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 065384
Suppliers and Packaging for NDA: 065384
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 065384 | ANDA | Chartwell RX, LLC. | 62135-615 | 62135-615-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-615-60) |
| CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 065384 | ANDA | Chartwell RX, LLC. | 62135-616 | 62135-616-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-616-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Aug 20, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 20, 2007 | TE: | AB | RLD: | No | ||||
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