Tri-sprintec
Drug - Tri-sprintec
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 -
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norgestimate. May repeat for multiple part products.
Applicant -
BARR
The firm name holding legal responsibility for Tri-sprintec. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
075808
The FDA assigned number to Tri-sprintec. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Tri-sprintec. 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 -
Dec 29, 2003
The date Tri-sprintec 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 Tri-sprintec. 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 Tri-sprintec is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Tri-sprintec.
Tri-sprintec
Previfem 0.035mg;0.25mg Tablet; Oral-28 Sprintec 0.035mg;0.25mg Tablet; Oral-28 Tri-previfem 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg Tablet; Oral-28 Tri-sprintec 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg 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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