Geopen

   
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Geopen


Drug - Geopen
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) - Carbenicillin Disodium
Multiple ingredients are in alphabetical order.

Strength - EQ 30GM BASE/VIAL
The potency of the active ingredient(s), Carbenicillin Disodium. May repeat for multiple part products.

Applicant - ROERIG
The firm name holding legal responsibility for Geopen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050306
The FDA assigned number to Geopen. Format is nnnnnn.

Product Number - 007
The FDA assigned number to identify Geopen. 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 Geopen 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 Geopen. 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 Geopen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Roerig Div Pfizer Inc
The full name of the firm holding legal responsibility for the new application of Geopen.

Geopen