Details for New Drug Application (NDA): 065322
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The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065322
Tradename: | AMOXICILLIN |
Applicant: | Hikma |
Ingredient: | amoxicillin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065322
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065322 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9888 | 0143-9888-01 | 100 mL in 1 BOTTLE (0143-9888-01) |
AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065322 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9888 | 0143-9888-15 | 150 mL in 1 BOTTLE (0143-9888-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
Approval Date: | Jun 19, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
Approval Date: | Jun 19, 2006 | TE: | AB | RLD: | No |
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