Tamoxifen Citrate

   
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Tamoxifen Citrate


Drug - Tamoxifen Citrate
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 10MG BASE
The potency of the active ingredient(s), Tamoxifen Citrate. May repeat for multiple part products.

Applicant - MYLAN
The firm name holding legal responsibility for Tamoxifen Citrate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074732
The FDA assigned number to Tamoxifen Citrate. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Tamoxifen Citrate. 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 - Feb 20, 2003
The date Tamoxifen Citrate 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 Tamoxifen Citrate. 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 Tamoxifen Citrate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mylan Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Tamoxifen Citrate.

Tamoxifen Citrate