Details for New Drug Application (NDA): 203584
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NDA 203584 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 203584
| Tradename: | CLARITHROMYCIN |
| Applicant: | Hec Pharm |
| Ingredient: | clarithromycin |
| Patents: | 0 |
Pharmacology for NDA: 203584
| Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 203584
Suppliers and Packaging for NDA: 203584
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 203584 | ANDA | Lannett Company, Inc. | 0527-1931 | 0527-1931-06 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1931-06) |
| CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 203584 | ANDA | Lannett Company, Inc. | 0527-1932 | 0527-1932-06 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1932-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Sep 28, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Sep 28, 2015 | TE: | AB | RLD: | No | ||||
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