Versapen-k

   
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Versapen-k


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

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

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

Strength - EQ 225MG AMPICIL
The potency of the active ingredient(s), Hetacillin Potassium. May repeat for multiple part products.

Applicant - BRISTOL
The firm name holding legal responsibility for Versapen-k. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 061396
The FDA assigned number to Versapen-k. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Versapen-k. 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 Versapen-k 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 Versapen-k. 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 Versapen-k is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Laboratories Inc Div Bristol Myers Co
The full name of the firm holding legal responsibility for the new application of Versapen-k.

Versapen-k