Demulen 1/50-21
Drug - Demulen 1/50-21
The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL-21
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Ethinyl Estradiol; Ethynodiol Diacetate
Multiple ingredients are in alphabetical order.
Strength -
0.05MG;1MG
The potency of the active ingredient(s), Ethinyl Estradiol; Ethynodiol Diacetate. May repeat for multiple part products.
Applicant -
GD SEARLE LLC
The firm name holding legal responsibility for Demulen 1/50-21. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
016927
The FDA assigned number to Demulen 1/50-21. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Demulen 1/50-21. 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 -
Approved Prior to Jan 1, 1982
The date Demulen 1/50-21 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 Demulen 1/50-21. 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 Demulen 1/50-21 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Gd Searle Llc
The full name of the firm holding legal responsibility for the new application of Demulen 1/50-21.
Demulen 1/50-21
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