Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container

   
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Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container


Drug - Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container
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 1.4MG BASE/ML
The potency of the active ingredient(s), Gentamicin Sulfate. May repeat for multiple part products.

Applicant - B BRAUN
The firm name holding legal responsibility for Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062814
The FDA assigned number to Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container. 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 - Aug 28, 1987
The date Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container 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 In Sodium Chloride 0.9% In Plastic Container. 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 In Sodium Chloride 0.9% In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - B Braun Medical Inc
The full name of the firm holding legal responsibility for the new application of Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container.

Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container