Details for New Drug Application (NDA): 065291
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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 065291
Tradename: | AMOXICILLIN |
Applicant: | Hikma Pharms |
Ingredient: | amoxicillin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065291
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | amoxicillin | CAPSULE;ORAL | 065291 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9939 | 0143-9939-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-05) |
AMOXICILLIN | amoxicillin | CAPSULE;ORAL | 065291 | ANDA | A-S Medication Solutions | 50090-0301 | 50090-0301-0 | 30 CAPSULE in 1 BOTTLE (50090-0301-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
Approval Date: | Feb 5, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 5, 2007 | TE: | AB | RLD: | No |
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