Zovirax

   
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Zovirax


Drug - Zovirax
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) - Acyclovir Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 1GM BASE/VIAL
The potency of the active ingredient(s), Acyclovir Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 018603
The FDA assigned number to Zovirax. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Zovirax. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jun 29, 1989
The date Zovirax 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 Zovirax. 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 Zovirax 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 Zovirax.

Zovirax