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Details for New Drug Application (NDA): 065129

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NDA 065129 describes SUPRAX, which is a drug marketed by Lederle, Lupin Pharms, and Lupin Ltd, and is included in eight NDAs. It is available from six suppliers. There is one patent protecting this drug. Additional details are available on the SUPRAX profile page.

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

Summary for NDA: 065129

Tradename:
SUPRAX
Applicant:
Lupin Pharms
Ingredient:
cefixime
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065129

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065129

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPRAX
cefixime
FOR SUSPENSION;ORAL 065129 ANDA Lupin Pharmaceuticals, Inc. 68180-202 68180-202-01 100 mL in 1 BOTTLE (68180-202-01)
SUPRAX
cefixime
FOR SUSPENSION;ORAL 065129 ANDA Lupin Pharmaceuticals, Inc. 68180-202 68180-202-02 75 mL in 1 BOTTLE (68180-202-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Feb 23, 2004TE:ABRLD: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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