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Generated: December 16, 2017

DrugPatentWatch Database Preview

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 eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the cefaclor profile page.

Summary for 064156

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
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 Physicians Total Care, Inc. 54868-3478 54868-3478-2 20 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-2)
CEFACLOR cefaclor CAPSULE;ORAL 064156 ANDA Physicians Total Care, Inc. 54868-3478 54868-3478-0 30 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-0)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Deloitte
Julphar
Teva
Queensland Health
Fish and Richardson
Argus Health
UBS
Daiichi Sankyo
Cerilliant
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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