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Details for New Drug Application (NDA): 062659

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NDA 062659 describes CLAFORAN, which is a drug marketed by Us Pharm Holdings and Sanofi Aventis Us and is included in three NDAs. It is available from two suppliers. Additional details are available on the CLAFORAN profile page.

The generic ingredient in CLAFORAN is cefotaxime sodium. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the cefotaxime sodium profile page.

Summary for NDA: 062659

Sanofi Aventis Us
cefotaxime sodium

Pharmacology for NDA: 062659


Suppliers and Packaging for NDA: 062659

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cefotaxime sodium
INJECTABLE;INJECTION 062659 ANDA Sanofi-Aventis U.S. LLC 0039-0023 0039-0023-25 25 VIAL in 1 PACKAGE (0039-0023-25) > 1 INJECTION in 1 VIAL
cefotaxime sodium
INJECTABLE;INJECTION 062659 ANDA Sanofi-Aventis U.S. LLC 0039-0024 0039-0024-25 25 VIAL in 1 PACKAGE (0039-0024-25) > 1 INJECTION in 1 VIAL

Summary for product number 001

Approval Date:Jan 13, 1987TE:APRLD:Yes

Summary for product number 002

Approval Date:Jan 13, 1987TE:APRLD: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.