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Generated: November 16, 2018

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Details for New Drug Application (NDA): 065429

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NDA 065429 describes CEFDINIR, which is a drug marketed by Aurobindo Pharma, Lupin, Orchid Hlthcare, Sandoz, and Teva Pharms, and is included in ten NDAs. It is available from thirty-one suppliers. Additional details are available on the CEFDINIR profile page.

The generic ingredient in CEFDINIR is cefdinir. There are twelve drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
Summary for 065429
Tradename:CEFDINIR
Applicant:Orchid Hlthcare
Ingredient:cefdinir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065429
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065429 ANDA OrchidPharma Inc 42043-251 42043-251-38 1 BOTTLE in 1 CARTON (42043-251-38) > 100 mL in 1 BOTTLE
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065429 ANDA OrchidPharma Inc 42043-251 42043-251-67 1 BOTTLE in 1 CARTON (42043-251-67) > 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Jul 18, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Jul 18, 2007TE:ABRLD:No

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