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Generated: December 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065412

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NDA 065412 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 065412
Tradename:CEFACLOR
Applicant:Yung Shin Pharm
Ingredient:cefaclor
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065412
Medical Subject Heading (MeSH) Categories for 065412
Suppliers and Packaging for NDA: 065412
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFACLOR cefaclor FOR SUSPENSION;ORAL 065412 ANDA Pack Pharmaceuticals, LLC 16571-070 16571-070-12 150 mL in 1 BOTTLE (16571-070-12)
CEFACLOR cefaclor FOR SUSPENSION;ORAL 065412 ANDA Pack Pharmaceuticals, LLC 16571-071 16571-071-12 150 mL in 1 BOTTLE (16571-071-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 125MG BASE/5ML
Approval Date:Feb 17, 2012TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 187MG BASE/5ML
Approval Date:Feb 17, 2012TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Feb 17, 2012TE:RLD:No

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