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Details for New Drug Application (NDA): 065119
The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-five drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065119
Tradename: | AMOXICILLIN |
Applicant: | Teva |
Ingredient: | amoxicillin |
Patents: | 0 |
Therapeutic Class: | Antibacterials |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065119
Ingredient-type | Penicillins |
Medical Subject Heading (MeSH) Categories for 065119
Suppliers and Packaging for NDA: 065119
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065119 | ANDA | Teva Pharmaceuticals USA Inc | 0093-4160 | N | 0093-4160-73 |
AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 065119 | ANDA | Teva Pharmaceuticals USA Inc | 0093-4160 | N | 0093-4160-76 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
Approval Date: | Dec 4, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 400MG/5ML | ||||
Approval Date: | Dec 4, 2002 | TE: | AB | RLD: | No |
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