Ultracef

   
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Ultracef


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

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

Active Ingredient(s) - Cefadroxil/cefadroxil Hemihydrate
Multiple ingredients are in alphabetical order.

Strength - EQ 1GM BASE
The potency of the active ingredient(s), Cefadroxil/cefadroxil Hemihydrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 062390
The FDA assigned number to Ultracef. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ultracef. 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 - Jun 10, 1982
The date Ultracef 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 Ultracef. 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 Ultracef 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 Ultracef.

Ultracef