Details for New Drug Application (NDA): 065283
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NDA 065283 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, Esjay Pharma, Hec Pharm, Hikma, Ivax Sub Teva Pharms, Norvium Bioscience, 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 065283
| Tradename: | CLARITHROMYCIN |
| Applicant: | Sandoz |
| Ingredient: | clarithromycin |
| Patents: | 0 |
Pharmacology for NDA: 065283
| Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 065283
Suppliers and Packaging for NDA: 065283
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | clarithromycin | FOR SUSPENSION;ORAL | 065283 | ANDA | Sandoz Inc | 0781-6022 | 0781-6022-46 | 100 mL in 1 BOTTLE (0781-6022-46) |
| CLARITHROMYCIN | clarithromycin | FOR SUSPENSION;ORAL | 065283 | ANDA | Sandoz Inc | 0781-6022 | 0781-6022-52 | 50 mL in 1 BOTTLE (0781-6022-52) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
| Approval Date: | Sep 4, 2007 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Sep 4, 2007 | TE: | RLD: | No | |||||
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