Natural Estrogenic Substance-estrone
Drug - Natural Estrogenic Substance-estrone
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) -
Estrone
Multiple ingredients are in alphabetical order.
Strength -
2MG/ML
The potency of the active ingredient(s), Estrone. May repeat for multiple part products.
Applicant -
STERIS
The firm name holding legal responsibility for Natural Estrogenic Substance-estrone. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
085237
The FDA assigned number to Natural Estrogenic Substance-estrone. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Natural Estrogenic Substance-estrone. 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 -
Nov 23, 1982
The date Natural Estrogenic Substance-estrone 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 Natural Estrogenic Substance-estrone. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Natural Estrogenic Substance-estrone is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Steris Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Natural Estrogenic Substance-estrone.
Natural Estrogenic Substance-estrone
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