Epipen

   
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Epipen


Drug - Epipen
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. The firm name is condensed to a maximum twenty character unique string.

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

Product Number - 001
The FDA assigned number to identify Epipen. 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 22, 1987
The date Epipen 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) - Yes
The pioneer or innovator of Epipen. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Epipen 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.

Epipen