Ortho Tri-cyclen Lo
Drug - Ortho Tri-cyclen Lo
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; Norgestimate
Multiple ingredients are in alphabetical order.
Strength -
0.025MG,0.025MG,0.25MG;0.18MG,0.215MG,0.25MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norgestimate. May repeat for multiple part products.
Applicant -
ORTHO MCNEIL PHARM
The firm name holding legal responsibility for Ortho Tri-cyclen Lo. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021241
The FDA assigned number to Ortho Tri-cyclen Lo. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Ortho Tri-cyclen Lo. 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 -
Aug 22, 2002
The date Ortho Tri-cyclen Lo 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 Tri-cyclen Lo. 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 Tri-cyclen Lo 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 Tri-cyclen Lo.
Ortho Tri-cyclen Lo
Microgestin Fe 1.5/30 0.03mg;1.5mg Tablet; Oral-28 Microgestin Fe 1/20 0.02mg;1mg Tablet; Oral-28 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate 0.02mg;1mg Tablet; Oral-28 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate 0.03mg;1.5mg Tablet; Oral-28 Norlestrin 28 1/50 0.05mg;1mg Tablet; Oral-28 Ortho Cyclen-21 0.035mg;0.25mg Tablet; Oral-21 Ortho Tri-cyclen 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg Tablet; Oral-21 Ortho Cyclen-28 0.035mg;0.25mg Tablet; Oral-28 Ortho Tri-cyclen 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg Tablet; Oral-28 Ortho Tri-cyclen Lo 0.025mg,0.025mg,0.25mg;0.18mg,0.215mg,0.25mg Tablet; Oral-28
NewDrugInformation
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