Ortho Evra

   
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Ortho Evra


Drug - Ortho Evra
The trade name of the product as shown on the labeling.

Dosage - FILM, EXTENDED RELEASE; TRANSDERMAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ethinyl Estradiol; Norelgestromin
Multiple ingredients are in alphabetical order.

Strength - 0.02MG/24HR;0.15MG/24HR
The potency of the active ingredient(s), Ethinyl Estradiol; Norelgestromin. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021180
The FDA assigned number to Ortho Evra. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ortho Evra. 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 - Nov 20, 2001
The date Ortho Evra 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 Evra. 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 Evra 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 Evra.

Ortho Evra