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Details for New Drug Application (NDA): 065261

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NDA 065261 describes CEFPROZIL, which is a drug marketed by Ranbaxy Labs Ltd, Teva, Apotex Inc, Wockhardt, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Lupin, Orchid Hlthcare, and Aurobindo Pharma, and is included in fifteen NDAs. It is available from nineteen suppliers. Additional details are available on the CEFPROZIL profile page.

The generic ingredient in CEFPROZIL is cefprozil. There are thirteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cefprozil profile page.

Summary for NDA: 065261

Therapeutic Class:Antibacterials

Pharmacology for NDA: 065261


Suppliers and Packaging for NDA: 065261

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOR SUSPENSION;ORAL 065261 ANDA A-S Medication Solutions LLC 54569-5785 54569-5785-0 100 mL in 1 BOTTLE (54569-5785-0)
FOR SUSPENSION;ORAL 065261 ANDA Physicians Total Care, Inc. 54868-5757 54868-5757-0 100 mL in 1 BOTTLE (54868-5757-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Dec 19, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Dec 19, 2005TE:ABRLD:Yes

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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.