Lymphazurin

   
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Lymphazurin


Drug - Lymphazurin
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) - Isosulfan Blue
Multiple ingredients are in alphabetical order.

Strength - 1%
The potency of the active ingredient(s), Isosulfan Blue. May repeat for multiple part products.

Applicant - US SURGCL
The firm name holding legal responsibility for Lymphazurin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018310
The FDA assigned number to Lymphazurin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lymphazurin. 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 - Approved Prior to Jan 1, 1982
The date Lymphazurin 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 Lymphazurin. 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 Lymphazurin is in. Format is RX, OTC, DISCN.

Applicant Full Name - United States Surgical Div Tyco Healthcare Group Lp
The full name of the firm holding legal responsibility for the new application of Lymphazurin.

Lymphazurin