Sprintec

   
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Sprintec


Drug - 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;0.25MG
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 Sprintec. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075804
The FDA assigned number to Sprintec. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify 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 - Sep 25, 2002
The date 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 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 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 Sprintec.

Sprintec