Details for New Drug Application (NDA): 208987
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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 208987
Tradename: | CLARITHROMYCIN |
Applicant: | Sunshine |
Ingredient: | clarithromycin |
Patents: | 0 |
Pharmacology for NDA: 208987
Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 208987
Suppliers and Packaging for NDA: 208987
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLARITHROMYCIN | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 208987 | ANDA | Lannett Company, Inc. | 0527-1930 | 0527-1930-06 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0527-1930-06) |
CLARITHROMYCIN | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 208987 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-942 | 43063-942-14 | 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-942-14) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Jul 9, 2018 | TE: | AB | RLD: | No |
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