Gentamicin Sulfate

   
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Gentamicin Sulfate


Drug - Gentamicin Sulfate
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) - Gentamicin Sulfate
Multiple ingredients are in alphabetical order.

Strength - EQ 40MG BASE/ML
The potency of the active ingredient(s), Gentamicin Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 062340
The FDA assigned number to Gentamicin Sulfate. Format is nnnnnn.

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

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

Approval Date - Mar 28, 1983
The date Gentamicin Sulfate 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 Gentamicin Sulfate. 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 Sulfate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmaceutical Specialist Assoc
The full name of the firm holding legal responsibility for the new application of Gentamicin Sulfate.

Gentamicin Sulfate