Nolvadex
Drug - Nolvadex
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) -
Tamoxifen Citrate
Multiple ingredients are in alphabetical order.
Strength -
EQ 20MG BASE
The potency of the active ingredient(s), Tamoxifen Citrate. May repeat for multiple part products.
Applicant -
ASTRAZENECA
The firm name holding legal responsibility for Nolvadex. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
017970
The FDA assigned number to Nolvadex. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Nolvadex. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Mar 21, 1994
The date Nolvadex 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 Nolvadex. 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 Nolvadex is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Astrazeneca Pharmaceuticals Lp
The full name of the firm holding legal responsibility for the new application of Nolvadex.
Nolvadex
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