Vitrasert

   
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Vitrasert


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

Dosage - IMPLANT; IMPLANTATION
The product dosage form and route separated by a semi-colon.

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

Strength - 4.5MG
The potency of the active ingredient(s), Ganciclovir. May repeat for multiple part products.

Applicant - BAUSCH AND LOMB
The firm name holding legal responsibility for Vitrasert. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020569
The FDA assigned number to Vitrasert. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Vitrasert. 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 - Mar 4, 1996
The date Vitrasert 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) - Yes
The pioneer or innovator of Vitrasert. 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 Vitrasert is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bausch And Lomb Inc
The full name of the firm holding legal responsibility for the new application of Vitrasert.

Vitrasert