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Generated: September 18, 2018

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Details for New Drug Application (NDA): 064164

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NDA 064164 describes CEFACLOR, which is a drug marketed by Ceph Intl, Dava Pharms Inc, Hikma, Ivax Sub Teva Pharms, Ranbaxy, Teva, Watson Labs Inc, Yung Shin Pharm, Facta Farma, and World Gen, and is included in twenty-nine NDAs. It is available from ten suppliers. Additional details are available on the CEFACLOR profile page.

The generic ingredient in CEFACLOR is cefaclor. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefaclor profile page.
Summary for 064164
Tradename:CEFACLOR
Applicant:Ranbaxy
Ingredient:cefaclor
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 064164
Suppliers and Packaging for NDA: 064164
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFACLOR cefaclor FOR SUSPENSION;ORAL 064164 ANDA Rebel Distributors Corp 21695-782 21695-782-15 150 mL in 1 BOTTLE (21695-782-15)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Oct 2, 1997TE:RLD:No

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