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Details for New Drug Application (NDA): 065370

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NDA 065370 describes CEFPODOXIME PROXETIL, which is a drug marketed by Aurobindo Pharma Ltd, Sandoz, Aurobindo Pharma, Sun Pharm Inds Ltd, and Orchid Hlthcare, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the CEFPODOXIME PROXETIL profile page.

The generic ingredient in CEFPODOXIME PROXETIL is cefpodoxime proxetil. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefpodoxime proxetil profile page.

Summary for NDA: 065370

Aurobindo Pharma
cefpodoxime proxetil
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065370


Suppliers and Packaging for NDA: 065370

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cefpodoxime proxetil
TABLET;ORAL 065370 ANDA NorthStar Rx LLC 16714-394 16714-394-01 20 TABLET, FILM COATED in 1 BOTTLE (16714-394-01)
cefpodoxime proxetil
TABLET;ORAL 065370 ANDA NorthStar Rx LLC 16714-395 16714-395-01 20 TABLET, FILM COATED in 1 BOTTLE (16714-395-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jun 11, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Jun 11, 2007TE:ABRLD:No

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