Retisert
Drug - Retisert
The trade name of the product as shown on the labeling.
Dosage -
IMPLANT; INTRAVITREAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Fluocinolone Acetonide
Multiple ingredients are in alphabetical order.
Strength -
0.59MG
The potency of the active ingredient(s), Fluocinolone Acetonide. May repeat for multiple part products.
Applicant -
BAUSCH AND LOMB
The firm name holding legal responsibility for Retisert. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021737
The FDA assigned number to Retisert. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Retisert. 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 -
Apr 8, 2005
The date Retisert 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 Retisert. 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 Retisert 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 Retisert.
Retisert
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