Details for New Drug Application (NDA): 210574
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The generic ingredient in CEFIXIME is cefixime. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the cefixime profile page.
Summary for 210574
Tradename: | CEFIXIME |
Applicant: | Alkem Labs Ltd |
Ingredient: | cefixime |
Patents: | 0 |
Suppliers and Packaging for NDA: 210574
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFIXIME | cefixime | CAPSULE;ORAL | 210574 | ANDA | Ascend Laboratories, LLC | 67877-584 | 67877-584-01 | 100 CAPSULE in 1 BOTTLE (67877-584-01) |
CEFIXIME | cefixime | CAPSULE;ORAL | 210574 | ANDA | Ascend Laboratories, LLC | 67877-584 | 67877-584-05 | 500 CAPSULE in 1 BOTTLE (67877-584-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
Approval Date: | Oct 9, 2018 | TE: | AB | RLD: | No |
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