Nebcin

   
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Nebcin


Drug - Nebcin
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 10MG BASE/ML
The potency of the active ingredient(s), Tobramycin Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050477
The FDA assigned number to Nebcin. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Nebcin. 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 Nebcin 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 Nebcin. 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 Nebcin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Eli Lilly And Co
The full name of the firm holding legal responsibility for the new application of Nebcin.

Nebcin