Neobiotic

   
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Neobiotic


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 350MG BASE
The potency of the active ingredient(s), Neomycin Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 060475
The FDA assigned number to Neobiotic. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Neobiotic. 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 Neobiotic 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 Neobiotic. 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 Neobiotic is in. Format is RX, OTC, DISCN.

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

Neobiotic