Estrostep 21

   
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Estrostep 21


Drug - Estrostep 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; Norethindrone Acetate
Multiple ingredients are in alphabetical order.

Strength - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norethindrone Acetate. May repeat for multiple part products.

Applicant - WARNER CHILCOTT
The firm name holding legal responsibility for Estrostep 21. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020130
The FDA assigned number to Estrostep 21. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Estrostep 21. 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 - Oct 9, 1996
The date Estrostep 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) - No
The pioneer or innovator of Estrostep 21. 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 Estrostep 21 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Warner Chilcott Inc
The full name of the firm holding legal responsibility for the new application of Estrostep 21.

Estrostep 21