Viagra

   
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Viagra


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 50MG BASE
The potency of the active ingredient(s), Sildenafil Citrate. May repeat for multiple part products.

Applicant - PFIZER IRELAND
The firm name holding legal responsibility for Viagra. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020895
The FDA assigned number to Viagra. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Viagra. 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 - Mar 27, 1998
The date Viagra 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 Viagra. 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 Viagra is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Ireland Pharmaceuticals
The full name of the firm holding legal responsibility for the new application of Viagra.

Viagra