Details for New Drug Application (NDA): 206714
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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 206714
Tradename: | CLARITHROMYCIN |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | clarithromycin |
Patents: | 0 |
Pharmacology for NDA: 206714
Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 206714
Suppliers and Packaging for NDA: 206714
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 206714 | ANDA | Ajanta Pharma USA Inc. | 27241-064 | 27241-064-06 | 60 TABLET in 1 BOTTLE (27241-064-06) |
CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 206714 | ANDA | Ajanta Pharma USA Inc. | 27241-065 | 27241-065-06 | 60 TABLET in 1 BOTTLE (27241-065-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Apr 25, 2019 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 25, 2019 | TE: | RLD: | No |
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