Details for New Drug Application (NDA): 202710
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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 202710
Tradename: | CLARITHROMYCIN |
Applicant: | Strides Pharma |
Ingredient: | clarithromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202710
Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 202710
Suppliers and Packaging for NDA: 202710
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 202710 | ANDA | Strides Pharma Science Limited | 64380-905 | 64380-905-03 | 60 TABLET, FILM COATED in 1 BOTTLE (64380-905-03) |
CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 202710 | ANDA | Strides Pharma Science Limited | 64380-906 | 64380-906-03 | 60 TABLET, FILM COATED in 1 BOTTLE (64380-906-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jun 10, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 10, 2013 | TE: | AB | RLD: | No |
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