Details for New Drug Application (NDA): 205707
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The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 205707
Tradename: | AMOXICILLIN AND CLAVULANATE POTASSIUM |
Applicant: | Micro Labs Ltd India |
Ingredient: | amoxicillin; clavulanate potassium |
Patents: | 0 |
Pharmacology for NDA: 205707
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 205707
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET;ORAL | 205707 | ANDA | Micro Labs Limited | 42571-160 | 42571-160-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42571-160-01) |
AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | TABLET;ORAL | 205707 | ANDA | Micro Labs Limited | 42571-160 | 42571-160-11 | 10 BLISTER PACK in 1 CARTON (42571-160-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-160-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG;EQ 125MG BASE | ||||
Approval Date: | Dec 30, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 125MG BASE | ||||
Approval Date: | Dec 30, 2016 | TE: | AB | RLD: | No |
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