Tobramycin

   
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Tobramycin


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

Strength - EQ 1.2GM BASE/VIAL
The potency of the active ingredient(s), Tobramycin Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050789
The FDA assigned number to Tobramycin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tobramycin. 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 - Jul 13, 2004
The date Tobramycin 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 Tobramycin. 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 Tobramycin is in. Format is RX, OTC, DISCN.

Applicant Full Name - American Pharmaceutical Partners Inc
The full name of the firm holding legal responsibility for the new application of Tobramycin.

Tobramycin