Details for New Drug Application (NDA): 065271
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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-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065271
Tradename: | AMOXICILLIN |
Applicant: | Aurobindo |
Ingredient: | amoxicillin |
Patents: | 0 |
Suppliers and Packaging for NDA: 065271
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN | amoxicillin | CAPSULE;ORAL | 065271 | ANDA | NorthStar Rx LLC | 16714-298 | 16714-298-01 | 100 CAPSULE in 1 BOTTLE (16714-298-01) |
AMOXICILLIN | amoxicillin | CAPSULE;ORAL | 065271 | ANDA | NorthStar Rx LLC | 16714-298 | 16714-298-02 | 500 CAPSULE in 1 BOTTLE (16714-298-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
Approval Date: | Nov 9, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Nov 9, 2005 | TE: | AB | RLD: | No |
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