Cefaclor

   
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Cefaclor


Drug - Cefaclor
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Cefaclor
Multiple ingredients are in alphabetical order.

Strength - EQ 500MG BASE
The potency of the active ingredient(s), Cefaclor. May repeat for multiple part products.

Applicant - TEVA
The firm name holding legal responsibility for Cefaclor. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 065058
The FDA assigned number to Cefaclor. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Cefaclor. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Sep 4, 2002
The date Cefaclor was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Cefaclor. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Cefaclor is in. Format is RX, OTC, DISCN.

Applicant Full Name - Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Cefaclor.

Cefaclor