Epipen E Z Pen

   
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Epipen E Z Pen


Drug - Epipen E Z Pen
The trade name of the product as shown on the labeling.

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

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

Strength - 0.3MG/DELIVERY
The potency of the active ingredient(s), Epinephrine. May repeat for multiple part products.

Applicant - MERIDIAN MEDCL TECHN
The firm name holding legal responsibility for Epipen E Z Pen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019430
The FDA assigned number to Epipen E Z Pen. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Epipen E Z Pen. 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 - Aug 3, 1995
The date Epipen E Z Pen 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 Epipen E Z Pen. 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 Epipen E Z Pen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Meridian Medical Technologies Inc
The full name of the firm holding legal responsibility for the new application of Epipen E Z Pen.

Epipen E Z Pen