Unipen

   
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Unipen


Drug - Unipen
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) - Nafcillin Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 2GM BASE/VIAL
The potency of the active ingredient(s), Nafcillin Sodium. May repeat for multiple part products.

Applicant - WYETH AYERST
The firm name holding legal responsibility for Unipen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062717
The FDA assigned number to Unipen. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Unipen. 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 - Dec 16, 1986
The date Unipen 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 Unipen. 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 Unipen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Wyeth Ayerst Laboratories
The full name of the firm holding legal responsibility for the new application of Unipen.

Unipen