Gentamicin

   
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Gentamicin


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

Dosage - OINTMENT; TOPICAL
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 0.1% BASE
The potency of the active ingredient(s), Gentamicin Sulfate. May repeat for multiple part products.

Applicant - CLAY PARK
The firm name holding legal responsibility for Gentamicin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062351
The FDA assigned number to Gentamicin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Gentamicin. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Feb 18, 1982
The date Gentamicin 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 Gentamicin. 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 Gentamicin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Clay Park Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Gentamicin.

Gentamicin