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Details for New Drug Application (NDA): 065058

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NDA 065058 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: 065058

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

Pharmacology for NDA: 065058

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065058

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFACLOR
cefaclor
TABLET, EXTENDED RELEASE;ORAL 065058 ANDA Teva Pharmaceuticals USA Inc 0093-1087 0093-1087-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 375MG BASE
Approval Date:Sep 4, 2002TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 500MG BASE
Approval Date:Sep 4, 2002TE:RLD:Yes


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