Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate

   
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Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate


Drug - Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
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) - Ethinyl Estradiol; Norethindrone Acetate
Multiple ingredients are in alphabetical order.

Strength - 0.03MG;1.5MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norethindrone Acetate. May repeat for multiple part products.

Applicant - ANDRX PHARMS
The firm name holding legal responsibility for Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 077075
The FDA assigned number to Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate. 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 - Apr 28, 2005
The date Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate 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 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate. 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 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Andrx Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate.

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate