Visionblue

   
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Visionblue


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

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

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

Strength - 0.06%
The potency of the active ingredient(s), Trypan Blue. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021670
The FDA assigned number to Visionblue. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Visionblue. 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 - Dec 16, 2004
The date Visionblue 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 Visionblue. 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 Visionblue is in. Format is RX, OTC, DISCN.

Applicant Full Name - Dorc International Bv
The full name of the firm holding legal responsibility for the new application of Visionblue.

Visionblue