Gentacidin

   
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Gentacidin


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

Dosage - SOLUTION/DROPS; OPHTHALMIC
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 0.3% BASE
The potency of the active ingredient(s), Gentamicin Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 062480
The FDA assigned number to Gentacidin. Format is nnnnnn.

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

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

Approval Date - Mar 30, 1984
The date Gentacidin 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 Gentacidin. 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 Gentacidin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Gentacidin.

Gentacidin