Genesa

   
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Genesa


Drug - Genesa
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) - Arbutamine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.05MG/ML
The potency of the active ingredient(s), Arbutamine Hydrochloride. May repeat for multiple part products.

Applicant - GENSIA AUTOMEDICS
The firm name holding legal responsibility for Genesa. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020420
The FDA assigned number to Genesa. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Genesa. 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 - Sep 12, 1997
The date Genesa 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 Genesa. 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 Genesa is in. Format is RX, OTC, DISCN.

Applicant Full Name - Gensia Automedics Inc
The full name of the firm holding legal responsibility for the new application of Genesa.

Genesa