Virazole

   
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Virazole


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

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

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

Strength - 6GM/VIAL
The potency of the active ingredient(s), Ribavirin. May repeat for multiple part products.

Applicant - VALEANT PHARM INTL
The firm name holding legal responsibility for Virazole. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018859
The FDA assigned number to Virazole. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Virazole. 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 31, 1985
The date Virazole 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 Virazole. 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 Virazole is in. Format is RX, OTC, DISCN.

Applicant Full Name - Valeant Pharmaceuticals International
The full name of the firm holding legal responsibility for the new application of Virazole.

Virazole