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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 Watson Labs Inc, Ceph Intl, Facta Farma, Dava Pharms Inc, Yung Shin Pharm, Teva, Hikma, Ranbaxy, World Gen, and Ivax Sub Teva Pharms, and is included in twenty-nine NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the cefaclor profile page.

Summary for NDA: 064164

Tradename:
CEFACLOR
Applicant:
Ranbaxy
Ingredient:
cefaclor
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

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)

Summary 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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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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