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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065350

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NDA 065350 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 065350

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065350

Ingredient-typeCephalosporins

Medical Subject Heading (MeSH) Categories for 065350

Suppliers and Packaging for NDA: 065350

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFACLOR cefaclor CAPSULE;ORAL 065350 ANDA West-Ward Pharmaceuticals Corp 0143-9985 0143-9985-01 100 CAPSULE in 1 BOTTLE (0143-9985-01)
CEFACLOR cefaclor CAPSULE;ORAL 065350 ANDA West-Ward Pharmaceuticals Corp 0143-9985 0143-9985-15 15 CAPSULE in 1 BOTTLE (0143-9985-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Apr 3, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Apr 3, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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Cipla

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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