Modicon 28

   
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Modicon 28


Drug - Modicon 28
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
Multiple ingredients are in alphabetical order.

Strength - 0.035MG;0.5MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norethindrone. May repeat for multiple part products.

Applicant - ORTHO MCNEIL PHARM
The firm name holding legal responsibility for Modicon 28. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017735
The FDA assigned number to Modicon 28. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Modicon 28. 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 - Approved Prior to Jan 1, 1982
The date Modicon 28 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 Modicon 28. 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 Modicon 28 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ortho Mcneil Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Modicon 28.

Modicon 28