Details for New Drug Application (NDA): 205187
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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 205187
Tradename: | AMOXICILLIN AND CLAVULANATE POTASSIUM |
Applicant: | Micro Labs Ltd India |
Ingredient: | amoxicillin; clavulanate potassium |
Patents: | 0 |
Pharmacology for NDA: 205187
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 205187
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 205187 | ANDA | Micro Labs Limited | 42571-163 | 42571-163-47 | 100 mL in 1 BOTTLE (42571-163-47) |
AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 205187 | ANDA | Micro Labs Limited | 42571-164 | 42571-164-47 | 100 mL in 1 BOTTLE (42571-164-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML;EQ 28.5MG BASE/5ML | ||||
Approval Date: | May 21, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 400MG/5ML;EQ 57MG BASE/5ML | ||||
Approval Date: | May 21, 2021 | TE: | AB | RLD: | No |
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