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Generated: October 20, 2018

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Details for New Drug Application (NDA): 064156

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NDA 064156 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 064156
Tradename:CEFACLOR
Applicant:Ranbaxy
Ingredient:cefaclor
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 064156
Suppliers and Packaging for NDA: 064156
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFACLOR cefaclor CAPSULE;ORAL 064156 ANDA bryant ranch prepack 63629-1305 63629-1305-5 6 CAPSULE in 1 BOTTLE (63629-1305-5)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Aug 28, 1997TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Aug 28, 1997TE:RLD:No

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