Cefadyl

   
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Cefadyl


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

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

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

New Drug Application (NDA) Number - 062961
The FDA assigned number to Cefadyl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cefadyl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Sep 20, 1988
The date Cefadyl 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 Cefadyl. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Apothecon Inc Div Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Cefadyl.

Cefadyl