Velivet

   
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Velivet


Drug - Velivet
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) - Desogestrel; Ethinyl Estradiol
Multiple ingredients are in alphabetical order.

Strength - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
The potency of the active ingredient(s), Desogestrel; Ethinyl Estradiol. May repeat for multiple part products.

Applicant - DURAMED PHARMS BARR
The firm name holding legal responsibility for Velivet. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076455
The FDA assigned number to Velivet. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Velivet. 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 - Feb 24, 2004
The date Velivet 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 Velivet. 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 Velivet is in. Format is RX, OTC, DISCN.

Applicant Full Name - Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Velivet.

Velivet