Details for New Drug Application (NDA): 065462
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The generic ingredient in CEFPODOXIME PROXETIL is cefpodoxime proxetil. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefpodoxime proxetil profile page.
Summary for 065462
Tradename: | CEFPODOXIME PROXETIL |
Applicant: | Sandoz |
Ingredient: | cefpodoxime proxetil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065462
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFPODOXIME PROXETIL | cefpodoxime proxetil | TABLET;ORAL | 065462 | ANDA | Sandoz Inc | 0781-5438 | 0781-5438-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5438-01) |
CEFPODOXIME PROXETIL | cefpodoxime proxetil | TABLET;ORAL | 065462 | ANDA | Sandoz Inc | 0781-5438 | 0781-5438-20 | 20 TABLET, FILM COATED in 1 BOTTLE (0781-5438-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | May 28, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
Approval Date: | May 28, 2008 | TE: | AB | RLD: | No |
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