Penbritin

   
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Penbritin


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

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

Active Ingredient(s) - Ampicillin/ampicillin Trihydrate
Multiple ingredients are in alphabetical order.

Strength - EQ 250MG BASE/5ML
The potency of the active ingredient(s), Ampicillin/ampicillin Trihydrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050019
The FDA assigned number to Penbritin. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Penbritin. 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 - Approved Prior to Jan 1, 1982
The date Penbritin 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 Penbritin. 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 Penbritin 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 Penbritin.

Penbritin