Premphase 14/14

   
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Premphase 14/14


Drug - Premphase 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 14/14. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020527
The FDA assigned number to Premphase 14/14. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Premphase 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 - Nov 17, 1995
The date Premphase 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) - Yes
The pioneer or innovator of Premphase 14/14. 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 Premphase 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 14/14.

Premphase 14/14