Ortho-novum 7/7/7-28
Drug - Ortho-novum 7/7/7-28
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,0.035MG,0.035MG;0.5MG,0.75MG,1MG
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 Ortho-novum 7/7/7-28. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018985
The FDA assigned number to Ortho-novum 7/7/7-28. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Ortho-novum 7/7/7-28. 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 -
Apr 4, 1984
The date Ortho-novum 7/7/7-28 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) -
Yes
The pioneer or innovator of Ortho-novum 7/7/7-28. 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 Ortho-novum 7/7/7-28 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 Ortho-novum 7/7/7-28.
Ortho-novum 7/7/7-28
Ortho-novum 10/11-28 0.035mg,0.035mg;0.5mg,1mg Tablet; Oral-28 Ortho-novum 7/14-28 0.035mg,0.035mg;0.5mg,1mg Tablet; Oral-28 Ortho-novum 7/7/7-28 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg Tablet; Oral-28 Norethindrone And Ethinyl Estradiol (10/11) 0.035mg,0.035mg;0.5mg,1mg Tablet; Oral-28 Norethindrone And Ethinyl Estradiol (7/14) 0.035mg,0.035mg;0.5mg,1mg Tablet; Oral-28 Norinyl 1+35 28-day 0.035mg;1mg Tablet; Oral-28 Nortrel 0.5/35-28 0.035mg;0.5mg Tablet; Oral-28 Nortrel 1/35-28 0.035mg;1mg Tablet; Oral-28 Nortrel 7/7/7 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg Tablet; Oral-28 Ortho-novum 1/35-28 0.035mg;1mg Tablet; Oral-28
NewDrugInformation
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