Cenestin
Drug - Cenestin
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) -
Estrogens, Conjugated Synthetic A
Multiple ingredients are in alphabetical order.
Strength -
0.45MG
The potency of the active ingredient(s), Estrogens, Conjugated Synthetic A. May repeat for multiple part products.
Applicant -
DURAMED
The firm name holding legal responsibility for Cenestin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020992
The FDA assigned number to Cenestin. Format is nnnnnn.
Product Number -
005
The FDA assigned number to identify Cenestin. 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 -
Feb 5, 2004
The date Cenestin 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 Cenestin. 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 Cenestin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Duramed Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Cenestin.
Cenestin
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