Premphase (premarin;cycrin 14/14)
Drug - Premphase (premarin;cycrin 14/14)
The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL-28
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Estrogens, Conjugated; Medroxyprogesterone Acetate
Multiple ingredients are in alphabetical order.
Strength -
0.625MG,0.625MG;N/A,5MG
The potency of the active ingredient(s), Estrogens, Conjugated; Medroxyprogesterone Acetate. May repeat for multiple part products.
Applicant -
WYETH PHARMS INC
The firm name holding legal responsibility for Premphase (premarin;cycrin 14/14). The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020303
The FDA assigned number to Premphase (premarin;cycrin 14/14). Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Premphase (premarin;cycrin 14/14). 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 -
Dec 30, 1994
The date Premphase (premarin;cycrin 14/14) 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 Premphase (premarin;cycrin 14/14). 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 Premphase (premarin;cycrin 14/14) is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Wyeth Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Premphase (premarin;cycrin 14/14).
Premphase (premarin;cycrin 14/14)
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