Dionosil Aqueous

   
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Dionosil Aqueous


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

Dosage - SUSPENSION; INTRATRACHEAL
The product dosage form and route separated by a semi-colon.

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

Strength - 50%
The potency of the active ingredient(s), Propyliodone. May repeat for multiple part products.

Applicant - GLAXOSMITHKLINE
The firm name holding legal responsibility for Dionosil Aqueous. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 009309
The FDA assigned number to Dionosil Aqueous. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Dionosil Aqueous. 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 Dionosil Aqueous 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 Dionosil Aqueous. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Dionosil Aqueous is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Dionosil Aqueous.

Dionosil Aqueous