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Details for New Drug Application (NDA): 050405

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NDA 050405 describes KEFLEX, which is a drug marketed by Pragma Pharms Llc and is included in two NDAs. It is available from two suppliers. Additional details are available on the KEFLEX profile page.

The generic ingredient in KEFLEX is cephalexin. There are twenty-nine drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the cephalexin profile page.

Summary for NDA: 050405

Tradename:
KEFLEX
Applicant:
Pragma Pharms Llc
Ingredient:
cephalexin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050405

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 050405

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KEFLEX
cephalexin
CAPSULE;ORAL 050405 NDA Pragma Pharmaceuticals, LLC 58463-011 58463-011-01 100 CAPSULE in 1 BOTTLE (58463-011-01)
KEFLEX
cephalexin
CAPSULE;ORAL 050405 NDA Pragma Pharmaceuticals, LLC 58463-012 58463-012-01 100 CAPSULE in 1 BOTTLE (58463-012-01)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 333MG BASE
Approval Date:May 12, 2006TE:RLD:No


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